3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog ID 03.010.060S Lot # 5558809, 6204324, 6813586, 7648837, 5559839, 6214366, 6818438, 7648838, 5575915, 6235676, 6827807, 7657752, 5579717, 6240287, 6830470, 7657753, 5582298, 6247514, 6835634, 7660380, 5585788, 6249834, 6841962, 7661528 5594237, 6269336, 6851101, 7661529, 5594238, 6276953, 6857546, 7674414, 5616439, 6279756, 6860704, 7687319, 5633067, 6279757, 6870563, 7693164, 5656914, 6302746, 6873394, 7716604, 5672506, 6313568, 6873396, 7731690 5682043, 6313569, 6898040, 7739027, 5692087, 6325420, 6904377, 7753584, 5702206, 6331923, 6908328, 7766654, 5711966, 6334954, 6919278, 7774127, 5724637, 6339936, 6925232, 7774128, 5727691, 6348925, 6931055, 7794479 5732158, 6355191, 6939080, 7817283, 5741332, 6368986, 6949503, 7830606, 5748361, 6375334, 6961056, 7835732, 5760640, 6382329, 6967764, 7848333, 5772367, 6398746, 6975982, 7869029, 5780654, 6413506, 6984973, 7870629 5782800, 6420887, 6996252, 7894923, 5782801, 6433683, 7004816, 7899079, 5782802, 6433684, 7013143, 7903010, 5794181, 6438144, 7019693, 7908522, 5816780, 6449832, 7029024, 7918012, 5818769, 6458079, 7036198, 7919639 5818770, 6464443, 7052563, 7924989, 5829138, 6475737, 7064072, 7941743, 5847359, 6480417, 7070681, 7947278, 5860702, 6486376, 7084937, 7963626, 5861834, 6488940, 7275546, 7981633, 5861836, 6505811, 7304754, 7993351 5870708, 6509276, 7349355, 9808655, 6010554, 6528479, 7359254, 9820617, 6031951, 6540263, 7371663, 9825386, 6034093, 6549146, 7382623, 9826363, 6034128, 6557658, 7400014, 9831036, 6051790, 6563112, 7400015, 9841499 6052762, 6572199, 7400016, 9855040, 6055036, 6577880, 7416878, 9859105, 6066429, 6586607, 7422660, 9864677, 6069150, 6593553, 7441691, 9869742, 6069151, 6598206, 7444103, 9878216, 6074684, 6603184, 7460590, 9886333 6080184, 6610704, 7465210, 9904888, 6081960, 6621162, 7476937, 9911126, 6091446, 6636693, 7485616, 9915461, 6092777, 6655352, 7497778, 9924572, 6109266, 6674053, 7499940, 9932287, 6121870, 6686555, 7512119, 9939768 6124816, 6707678, 7520264, 9959608, 6130838, 6721722, 7533286, 9961574, 6133623, 6733633, 7544212, 9970453, 6136836, 6752258, 7554690, 9985425, 6141455, 6761019, 7563621, H023093, 6153365, 6766654, 7636777, H024812 6163583, 6777654, 7636778, H034525, 6186051, 6786129, 7636779, H039109, 6186052, 6796018, 7648835, 6187891, 6796019, 7648836
- 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:
- Synthes (USA) Products LLC
- Reason for Recall:
- The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
Product Codes/Lot Numbers:
Catalog ID 03.010.060S Lot # 5558809, 6204324, 6813586, 7648837, 5559839, 6214366, 6818438, 7648838, 5575915, 6235676, 6827807, 7657752, 5579717, 6240287, 6830470, 7657753, 5582298, 6247514, 6835634, 7660380, 5585788, 6249834, 6841962, 7661528 5594237, 6269336, 6851101, 7661529, 5594238, 6276953, 6857546, 7674414, 5616439, 6279756, 6860704, 7687319, 5633067, 6279757, 6870563, 7693164, 5656914, 6302746, 6873394, 7716604, 5672506, 6313568, 6873396, 7731690 5682043, 6313569, 6898040, 7739027, 5692087, 6325420, 6904377, 7753584, 5702206, 6331923, 6908328, 7766654, 5711966, 6334954, 6919278, 7774127, 5724637, 6339936, 6925232, 7774128, 5727691, 6348925, 6931055, 7794479 5732158, 6355191, 6939080, 7817283, 5741332, 6368986, 6949503, 7830606, 5748361, 6375334, 6961056, 7835732, 5760640, 6382329, 6967764, 7848333, 5772367, 6398746, 6975982, 7869029, 5780654, 6413506, 6984973, 7870629 5782800, 6420887, 6996252, 7894923, 5782801, 6433683, 7004816, 7899079, 5782802, 6433684, 7013143, 7903010, 5794181, 6438144, 7019693, 7908522, 5816780, 6449832, 7029024, 7918012, 5818769, 6458079, 7036198, 7919639 5818770, 6464443, 7052563, 7924989, 5829138, 6475737, 7064072, 7941743, 5847359, 6480417, 7070681, 7947278, 5860702, 6486376, 7084937, 7963626, 5861834, 6488940, 7275546, 7981633, 5861836, 6505811, 7304754, 7993351 5870708, 6509276, 7349355, 9808655, 6010554, 6528479, 7359254, 9820617, 6031951, 6540263, 7371663, 9825386, 6034093, 6549146, 7382623, 9826363, 6034128, 6557658, 7400014, 9831036, 6051790, 6563112, 7400015, 9841499 6052762, 6572199, 7400016, 9855040, 6055036, 6577880, 7416878, 9859105, 6066429, 6586607, 7422660, 9864677, 6069150, 6593553, 7441691, 9869742, 6069151, 6598206, 7444103, 9878216, 6074684, 6603184, 7460590, 9886333 6080184, 6610704, 7465210, 9904888, 6081960, 6621162, 7476937, 9911126, 6091446, 6636693, 7485616, 9915461, 6092777, 6655352, 7497778, 9924572, 6109266, 6674053, 7499940, 9932287, 6121870, 6686555, 7512119, 9939768 6124816, 6707678, 7520264, 9959608, 6130838, 6721722, 7533286, 9961574, 6133623, 6733633, 7544212, 9970453, 6136836, 6752258, 7554690, 9985425, 6141455, 6761019, 7563621, H023093, 6153365, 6766654, 7636777, H024812 6163583, 6777654, 7636778, H034525, 6186051, 6786129, 7636779, H039109, 6186052, 6796018, 7648835, 6187891, 6796019, 7648836
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1709-2016
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