Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature. The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space. The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring. The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage. The Camino 110-4L catheter is intended for use with the Licox¿ Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.

Class I - Dangerous

🏥 Medical Devices Recalled: September 10, 2013 Integra Limited Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. Lot Numbers: Catalog Number 110-4B: 3050RX195484, 3050RX198473, 305000205426, 3050RX197641, 3050RX201421, 305000205648, 305000205652, 3050RX199149, 3050RX201407, 3050RX199850, 305000205976, 3050RY189979, 3050RX200862, 305000206178, 3050RY193648, 3050RX200486, 3050RX181026, 3050RX185115, 3050RY195484, 305000207061, 305000207062, 3050RY198473, 305000207330, 305000207334, 3050RY197641, 3050RY200862, 305000207580, 305000207892, 3050RY200486, 3050RY181026, 3050RY185115, 3050RX207330, 3050RX207334, 3050RX207580, 305000208008, 305000208510, 3050RY207892, 305000210060, 3050RX208008, 3050RX208510, 3050RX205976, 3050RX206178, 305000210563, 305000211723, 3050RX210060, 305000212616, 305000213007, 305000213191, 30500X210563, 3050RX207061, 305000214590, 3050RX205426, 30500X215502, 3050RX207062, 305000215531, 30500X216410, 3050RY199850, 305000216132, 30500X216627, 30500X217119, 3050RY217112, 305000216718, 3050RX217751, 3050RX217840, 3050RY217837, 305000217858, 30500X218369, 30500X218391, 30500X219054, 3050RY206178, 305000220708, 305000218578, 30500X220430, 305000219261, 30500X221221, 305000221226, 305000219989, 30500X222569, 305000221953, 305000221955, 30500X223153, 30500X223709, 305000223275, 305000223280, 305000222640, 30500X224142, 305000223867, 305000223866, 30500X224692, 305000224352, 305000224353, 30500X225386, 305000225045, 305000225044, 30500X225992, 305000225632, 305000225633, 30500X226540, 30500X227059, 305000226844, 305000226846, 305000226127, 30500X227564, 305000226836, 30500X227820, 305000227127, 305000227128, 30500X228194, 305000227790, 305000227789, 30500X228787, 305000228522, 305000228521, 305000228971, 305000228972, 30500X229560, 305000229328, 305000229329, 30500X229766, 30500X230087, 305000229825, 305000229826, 30500X230565, 305000230303, 305000230302, 30500X231053, 305000230780, 305000230781, 30500X231786, 305000231461, 305000231462, 30500X232331, 305000232098, 305000232099, 30500X232960, 305000232605, 305000232604, 305000233245, 305000233244, 305000233243, 305000233242, 305000233241, 305000233240, 30500X233415, 30500X234183, 305000233607, 305000233608, 30500X234806, 305000234303, 305000234304, 305000235022, 305000235017, 30500X235732, 305000235598, 30500X236328, 305000236105, 305000236104, 305000236655, 305000236653, 30500Y237087, 30500X237090, 305000237232, 30500X237761, 305000237824, 305000237825, 30500X238273, 305000238263, 305000238264, 30500X239095, 305000238818, 305000238819, 30500X239497, 30500X239748, 30500X239958, 30500X240334, 30500X240668, 30500X241368, 305000241516, 305000242236, 305000242792, 305000242795, 305000242796, 305000242794, 305000242793, 305000242791, 3050RY243869, 305000243251, 305000243882, 305000243881, 305000243888, 305000243889, 305000243883, 30500X244281, 30500X244880, 305000244513,30500X245306, 305000244481, 305000244480, 305000244934, 30500X245937, 30500X246067, 305000245408, 30500X246872, 305000245835, 30500X246951, 30500X247608, 305000246460, 30500X248284, 305000247007, 3050RX227127, 3050RX234303, 305000247717, 305000249072, 3050RX242794, 3050RX242793, 3050RX237825, 3050RX241516, 30500X249488, 305000248479, 30500X250423, 305000249743, 30500X250964, 305000250456, 30500X251060, 305000251055, 30500X251560, 30500X252133, 3050RY252136, 305000251453, 30500X252771, 305000252058, 3050RX244513, 305000252646, 305000253785, 30500X254929, 3050RY255145, 30500X255141, 305000254589, 305000255549, 305000255551, 305000255038, 30500X256614, 305000256192, 305000257281, 305000256709, 305000257280, 305000258048, 30500X259385, 305000258379, 305000258921, 305000258922, 30500X259557, 305000259431, 305000259432, 30500X260159, 305000259966, 305000259960, 305000260514, 305000260527, 30500Y261748, 3050RX253785, 305000261325, 305000261326, 305000261737, 305000261736, 3050RX256192, 30500X262441, 305000262328, 305000262327, 305000262978, 305000262977, 3050RY263508, 30500X263559, 305000263504, 305000264073, 305000264074, 305000264625, 305000264624, 3050RY265348, 30500X265422, 30500X265976, 3050RY265975, 305000265530, 305000265527, 30500X266142, 305000266134, 305000266135, 30500X266789, 305000267193, 305000267194, 3050RX261325, 30500X267468, 305000267421, 305000267422, 30500X267990, 305000267673, 305000267674, 305000268294, 305000268293, 305000266784, 305000268914, 305000268915, 3050RX261736, 3050RY269955, 30500X269963, 305000269220, 305000269221, 305000270081, 3050RY271045, 30500X271047, 305000271042, 305000271716, 305000271715, 30500X272367, 305000272273, 305000272274, 305000272852, 305000272851, 30500X274204, 305000273466, 305000273463, 305000274200, 305000274201, 30500X275297, 30500X275393, 305000274816, 30500X276594, 3050RX268914, 305000277761, 3050RY282196, 305000282304, 30500X282815, 3050RY283371, 3050RX283315, 3050RX283314 Catalog Number 110-4G: 3050RX195650, 3050RX198690, 3050RY193969, 3050RY197837, 3050RX199151, 3050RX199942, 3050RX201552, 3050RY185259, 3050RX200538, 305000206177, 3050RX200989, 305000206556, 305000206557, 3050RX200990, 3050RY199151, 3050RY199942, 305000207465, 3050RY200538, 3050RY200989, 305000208007, 3050RY200990, 3050RX207465, 3050RX206557, 3050RX206556, 305000209417, 305000209105, 3050RX208007, 305000210891, 305000211419, 3050RX206177, 30500X209105, 3050RX209417, 305000212298, 30500X210891, 305000213240, 305000214103, 30500X215501, 30500X215577, 3050RX202201, 305000215628, 3050RY195650, 3050RY198690, 30500X216621, 305000216246,3050RY217113, 30500X217118, 305000217140, 30500X217835, 3050RY217839, 305000217464, 30500X218393, 305000218009, 30500X219053, 305000218225, 305000219118, 30500X220001, 30500X220429, 305000219990, 30500X221225, 305000221227, 30500X222567, 305000222642, 305000223279, 30500X223707, 305000223868, 30500X224685, 305000224354, 30500X225383, 305000225046, 305000225634, 30500X226000, 30500X226541, 305000226731, 305000226869, 305000226867, 30500X227567, 305000227129, 30500X228784, 305000228523, 305000228973, 30500X229561, 305000229330, 30500X230084, 305000229827, 305000230304, 30500X231054,305000230782, 30500X231787, 305000231463, 30500X232333, 305000232101, 30500X232776, 305000232606, 30500X233419, 305000233246, 305000233609, 30500X234690, 30500X234807, 305000234306, 305000235566, 30500X236329, 30500Y237088, 30500X237767, 305000237233, 305000238820, 30500X239496, 305000239476, 30500X240336, 30500X241357, 305000241518, 30500X242172, 305000242249, 305000243252, 305000244364, 30500X245304, 305000244935, 305000245409, 305000245838, 30500X246522, 305000246308, 30500X246873, 30500X247609, 30500X248281, 305000249073, 3050RX241518, 3050RX233246, 3050RX242249, 3050RX228973, 30500X251061, 305000251056, 30500X251563, 3050RY252137, 305000252059, 305000252648, 305000254591, 30500X254931, 30500X255143, 305000255039, 305000255548, 305000256193, 305000256737, 305000257244, 305000257246, 305000257921, 305000257920, 305000258303, 305000258290, 30500X259383, 305000258793, 305000259573, 30500X260163, 305000259958, 305000259959, 3050RX254591, 3050RX255039, 305000260513, 305000260512, 30500Y261771, 3050RX257244, 3050RX257920, 305000261159, 305000261160, 3050RY262444, 30500X262443, 305000261734, 305000261732, 305000262325, 305000262326, 3050RX258303, 305000262976, 305000262975, 3050RY263510, 30500X263560, 305000263507, 305000263506, 305000264075, 305000264076, 305000264627, 305000264628, 30500X265424, 305000265525, 305000265524, 30500X265978, 30500X266143, 305000266063, 305000266064, 30500X266787, 305000266638, 305000266637, 305000267191, 30500X267470, 305000267423, 305000267675, 3050RY269957, 30500X274206 Catalog Number 110-4H: 3050RX198281, 3050RY194144, 3050RY198281, 3050RY200861, 30500X223154, 305000220948, 305000223622, 30500X225385, 30500X233417, 305000231714, 305000241350, 30500X243874, 305000250959, 30500X254932, 305000263557 Catalog Number 110-4L: 305000221383, 30500X222566, 305000222762, 30500X223971,305000223969, 305000225078, 30500X226539, 305000226221, 30500X227058, 305000226848, 305000226749, 305000226847, 305000226871, 305000226,870, 30500X228783, 305000229450, 305000229909, 305000230871 30500X232775, 305000232199, 30500X232961, 305000233311, 305000234438, 30500X235731, 305000235181, 305000236201, 305000237368, 305000237369, 305000237799, 305000238539, 305000239102, 30500X240245, 30500X240246, 30500X240247, 305000239736, 305000239737, 30500X241365, 30500X241522, 305000241082, 30500X242170, 30500X245765, 30500X246521, 3050RX237799, 3050RX226749, 3050RX229450, 3050RX241082, 3050RX232199, 3050RY252775, 3050RX240446, 3050RY255148, 305000259553, 305000260626, 305000261835, 305000262436, 3050RX259553, 305000263146, 3050RX260626, 305000264077, 3050RX262436, 3050RX261835, 305000264175, 3050RY265351, 3050RY265766, 305000265531, 30500X266144, 3050RY266146, 30500X266522, 305000266062, 305000267297, 30500X267473, 30500X268133, 305000267784, 305000268412, 3050RX265531, 305000268916, 3050RY271046, 305000271872, 30500X272374, 305000272591, 30500X274210, 30500X274963, 305000281820 Catalog Number 110-4BC: 176044, 177018, 178013, 178898, 179757, 180139, 180955, 182279, 182908, 184079, 184687, 185284, 186277, 187293, 190452, 187780, 190451, 191891, 193414, 194074, 195161, 195608, 196987, 197492, 198189, 198512, 200069, 200490, 199609, 201039, 201595, 202423, 203565, 207077, 208532 Catalog Number 110-4HC: 179758, 180956, 183071, 184686, 186278, 187781, 190450, 192246, 194993, 195450, 198191, 199708, 201040, 201596, 202009 Catalog Number 110-4LC: 162523, 167450, 167786, 175720, 177188, 178547, 182130, 187495, 195245, 197493.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Integra Limited
Reason for Recall:: Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, certain Camino¿ Intracranial Pressure Monitoring Kits require additional labelling to indicate they are UNSAFE in an MR environment. Only the following Camino¿ Intracranial Pressure Monitoring Kits are affected: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature. The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space. The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring. The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage. The Camino 110-4L catheter is intended for use with the Licox¿ Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.

Product Codes/Lot Numbers:

Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. Lot Numbers: Catalog Number 110-4B: 3050RX195484, 3050RX198473, 305000205426, 3050RX197641, 3050RX201421, 305000205648, 305000205652, 3050RX199149, 3050RX201407, 3050RX199850, 305000205976, 3050RY189979, 3050RX200862, 305000206178, 3050RY193648, 3050RX200486, 3050RX181026, 3050RX185115, 3050RY195484, 305000207061, 305000207062, 3050RY198473, 305000207330, 305000207334, 3050RY197641, 3050RY200862, 305000207580, 305000207892, 3050RY200486, 3050RY181026, 3050RY185115, 3050RX207330, 3050RX207334, 3050RX207580, 305000208008, 305000208510, 3050RY207892, 305000210060, 3050RX208008, 3050RX208510, 3050RX205976, 3050RX206178, 305000210563, 305000211723, 3050RX210060, 305000212616, 305000213007, 305000213191, 30500X210563, 3050RX207061, 305000214590, 3050RX205426, 30500X215502, 3050RX207062, 305000215531, 30500X216410, 3050RY199850, 305000216132, 30500X216627, 30500X217119, 3050RY217112, 305000216718, 3050RX217751, 3050RX217840, 3050RY217837, 305000217858, 30500X218369, 30500X218391, 30500X219054, 3050RY206178, 305000220708, 305000218578, 30500X220430, 305000219261, 30500X221221, 305000221226, 305000219989, 30500X222569, 305000221953, 305000221955, 30500X223153, 30500X223709, 305000223275, 305000223280, 305000222640, 30500X224142, 305000223867, 305000223866, 30500X224692, 305000224352, 305000224353, 30500X225386, 305000225045, 305000225044, 30500X225992, 305000225632, 305000225633, 30500X226540, 30500X227059, 305000226844, 305000226846, 305000226127, 30500X227564, 305000226836, 30500X227820, 305000227127, 305000227128, 30500X228194, 305000227790, 305000227789, 30500X228787, 305000228522, 305000228521, 305000228971, 305000228972, 30500X229560, 305000229328, 305000229329, 30500X229766, 30500X230087, 305000229825, 305000229826, 30500X230565, 305000230303, 305000230302, 30500X231053, 305000230780, 305000230781, 30500X231786, 305000231461, 305000231462, 30500X232331, 305000232098, 305000232099, 30500X232960, 305000232605, 305000232604, 305000233245, 305000233244, 305000233243, 305000233242, 305000233241, 305000233240, 30500X233415, 30500X234183, 305000233607, 305000233608, 30500X234806, 305000234303, 305000234304, 305000235022, 305000235017, 30500X235732, 305000235598, 30500X236328, 305000236105, 305000236104, 305000236655, 305000236653, 30500Y237087, 30500X237090, 305000237232, 30500X237761, 305000237824, 305000237825, 30500X238273, 305000238263, 305000238264, 30500X239095, 305000238818, 305000238819, 30500X239497, 30500X239748, 30500X239958, 30500X240334, 30500X240668, 30500X241368, 305000241516, 305000242236, 305000242792, 305000242795, 305000242796, 305000242794, 305000242793, 305000242791, 3050RY243869, 305000243251, 305000243882, 305000243881, 305000243888, 305000243889, 305000243883, 30500X244281, 30500X244880, 305000244513,30500X245306, 305000244481, 305000244480, 305000244934, 30500X245937, 30500X246067, 305000245408, 30500X246872, 305000245835, 30500X246951, 30500X247608, 305000246460, 30500X248284, 305000247007, 3050RX227127, 3050RX234303, 305000247717, 305000249072, 3050RX242794, 3050RX242793, 3050RX237825, 3050RX241516, 30500X249488, 305000248479, 30500X250423, 305000249743, 30500X250964, 305000250456, 30500X251060, 305000251055, 30500X251560, 30500X252133, 3050RY252136, 305000251453, 30500X252771, 305000252058, 3050RX244513, 305000252646, 305000253785, 30500X254929, 3050RY255145, 30500X255141, 305000254589, 305000255549, 305000255551, 305000255038, 30500X256614, 305000256192, 305000257281, 305000256709, 305000257280, 305000258048, 30500X259385, 305000258379, 305000258921, 305000258922, 30500X259557, 305000259431, 305000259432, 30500X260159, 305000259966, 305000259960, 305000260514, 305000260527, 30500Y261748, 3050RX253785, 305000261325, 305000261326, 305000261737, 305000261736, 3050RX256192, 30500X262441, 305000262328, 305000262327, 305000262978, 305000262977, 3050RY263508, 30500X263559, 305000263504, 305000264073, 305000264074, 305000264625, 305000264624, 3050RY265348, 30500X265422, 30500X265976, 3050RY265975, 305000265530, 305000265527, 30500X266142, 305000266134, 305000266135, 30500X266789, 305000267193, 305000267194, 3050RX261325, 30500X267468, 305000267421, 305000267422, 30500X267990, 305000267673, 305000267674, 305000268294, 305000268293, 305000266784, 305000268914, 305000268915, 3050RX261736, 3050RY269955, 30500X269963, 305000269220, 305000269221, 305000270081, 3050RY271045, 30500X271047, 305000271042, 305000271716, 305000271715, 30500X272367, 305000272273, 305000272274, 305000272852, 305000272851, 30500X274204, 305000273466, 305000273463, 305000274200, 305000274201, 30500X275297, 30500X275393, 305000274816, 30500X276594, 3050RX268914, 305000277761, 3050RY282196, 305000282304, 30500X282815, 3050RY283371, 3050RX283315, 3050RX283314 Catalog Number 110-4G: 3050RX195650, 3050RX198690, 3050RY193969, 3050RY197837, 3050RX199151, 3050RX199942, 3050RX201552, 3050RY185259, 3050RX200538, 305000206177, 3050RX200989, 305000206556, 305000206557, 3050RX200990, 3050RY199151, 3050RY199942, 305000207465, 3050RY200538, 3050RY200989, 305000208007, 3050RY200990, 3050RX207465, 3050RX206557, 3050RX206556, 305000209417, 305000209105, 3050RX208007, 305000210891, 305000211419, 3050RX206177, 30500X209105, 3050RX209417, 305000212298, 30500X210891, 305000213240, 305000214103, 30500X215501, 30500X215577, 3050RX202201, 305000215628, 3050RY195650, 3050RY198690, 30500X216621, 305000216246,3050RY217113, 30500X217118, 305000217140, 30500X217835, 3050RY217839, 305000217464, 30500X218393, 305000218009, 30500X219053, 305000218225, 305000219118, 30500X220001, 30500X220429, 305000219990, 30500X221225, 305000221227, 30500X222567, 305000222642, 305000223279, 30500X223707, 305000223868, 30500X224685, 305000224354, 30500X225383, 305000225046, 305000225634, 30500X226000, 30500X226541, 305000226731, 305000226869, 305000226867, 30500X227567, 305000227129, 30500X228784, 305000228523, 305000228973, 30500X229561, 305000229330, 30500X230084, 305000229827, 305000230304, 30500X231054,305000230782, 30500X231787, 305000231463, 30500X232333, 305000232101, 30500X232776, 305000232606, 30500X233419, 305000233246, 305000233609, 30500X234690, 30500X234807, 305000234306, 305000235566, 30500X236329, 30500Y237088, 30500X237767, 305000237233, 305000238820, 30500X239496, 305000239476, 30500X240336, 30500X241357, 305000241518, 30500X242172, 305000242249, 305000243252, 305000244364, 30500X245304, 305000244935, 305000245409, 305000245838, 30500X246522, 305000246308, 30500X246873, 30500X247609, 30500X248281, 305000249073, 3050RX241518, 3050RX233246, 3050RX242249, 3050RX228973, 30500X251061, 305000251056, 30500X251563, 3050RY252137, 305000252059, 305000252648, 305000254591, 30500X254931, 30500X255143, 305000255039, 305000255548, 305000256193, 305000256737, 305000257244, 305000257246, 305000257921, 305000257920, 305000258303, 305000258290, 30500X259383, 305000258793, 305000259573, 30500X260163, 305000259958, 305000259959, 3050RX254591, 3050RX255039, 305000260513, 305000260512, 30500Y261771, 3050RX257244, 3050RX257920, 305000261159, 305000261160, 3050RY262444, 30500X262443, 305000261734, 305000261732, 305000262325, 305000262326, 3050RX258303, 305000262976, 305000262975, 3050RY263510, 30500X263560, 305000263507, 305000263506, 305000264075, 305000264076, 305000264627, 305000264628, 30500X265424, 305000265525, 305000265524, 30500X265978, 30500X266143, 305000266063, 305000266064, 30500X266787, 305000266638, 305000266637, 305000267191, 30500X267470, 305000267423, 305000267675, 3050RY269957, 30500X274206 Catalog Number 110-4H: 3050RX198281, 3050RY194144, 3050RY198281, 3050RY200861, 30500X223154, 305000220948, 305000223622, 30500X225385, 30500X233417, 305000231714, 305000241350, 30500X243874, 305000250959, 30500X254932, 305000263557 Catalog Number 110-4L: 305000221383, 30500X222566, 305000222762, 30500X223971,305000223969, 305000225078, 30500X226539, 305000226221, 30500X227058, 305000226848, 305000226749, 305000226847, 305000226871, 305000226,870, 30500X228783, 305000229450, 305000229909, 305000230871 30500X232775, 305000232199, 30500X232961, 305000233311, 305000234438, 30500X235731, 305000235181, 305000236201, 305000237368, 305000237369, 305000237799, 305000238539, 305000239102, 30500X240245, 30500X240246, 30500X240247, 305000239736, 305000239737, 30500X241365, 30500X241522, 305000241082, 30500X242170, 30500X245765, 30500X246521, 3050RX237799, 3050RX226749, 3050RX229450, 3050RX241082, 3050RX232199, 3050RY252775, 3050RX240446, 3050RY255148, 305000259553, 305000260626, 305000261835, 305000262436, 3050RX259553, 305000263146, 3050RX260626, 305000264077, 3050RX262436, 3050RX261835, 305000264175, 3050RY265351, 3050RY265766, 305000265531, 30500X266144, 3050RY266146, 30500X266522, 305000266062, 305000267297, 30500X267473, 30500X268133, 305000267784, 305000268412, 3050RX265531, 305000268916, 3050RY271046, 305000271872, 30500X272374, 305000272591, 30500X274210, 30500X274963, 305000281820 Catalog Number 110-4BC: 176044, 177018, 178013, 178898, 179757, 180139, 180955, 182279, 182908, 184079, 184687, 185284, 186277, 187293, 190452, 187780, 190451, 191891, 193414, 194074, 195161, 195608, 196987, 197492, 198189, 198512, 200069, 200490, 199609, 201039, 201595, 202423, 203565, 207077, 208532 Catalog Number 110-4HC: 179758, 180956, 183071, 184686, 186278, 187781, 190450, 192246, 194993, 195450, 198191, 199708, 201040, 201596, 202009 Catalog Number 110-4LC: 162523, 167450, 167786, 175720, 177188, 178547, 182130, 187495, 195245, 197493.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0117-2014

Related Recalls

Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.

Integra Limited

Class I - Dangerous

Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months

Mar 31, 2019 Surgical Instruments Nationwide View Details →

Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.

Integra Limited

Class I - Dangerous

Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F

Mar 1, 2019 Implants & Prosthetics Nationwide View Details →

Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.

Integra Limited

Class I - Dangerous

Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F

Mar 1, 2019 Implants & Prosthetics Nationwide View Details →