smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 71331842, Lot Numbers: 18HM20691, 18LM09819, 18KM1572 71331848, Lot Numbers: 18HM01685, 19AM15804, 19AM15805, 19AM15809, 19AM15828, 19AM15829 71331850, Lot Numbers: 18LM00667, 18LM00668, 18LM00670, 18LM00671, 18LM00702, 18LM00668A, 18LM00671A 71331852, Lot Numbers: 19EM10292, 18KM20315, 18KM15739, 18KM20284, 18LM17941, 18LM02317, 18KM00744, 18KM00775, 18KM00779, 18KM00833, 18KM06667, 18KM06675, 18KM06676, 18KM06680, 18KM06681, 18KM06682, 18KM13594, 18KM13632, 18KM15736, 18KM15737, 18KM15738, 18KM20281, 18KM20289, 18KM20291, 18KM20292, 18KM24785, 18KM24792, 18KM24795, 18KM24805, 18LM02315, 18LM02337, 18LM17942, 18LM17946, 18KM20281A, 18LM07653, 18KM15736A, 18LM14077, 18KM24785A, 18KM20293A 71331854, Lot Numbers: 18JM13875, 18mm08723, 18JM13874, 19AM17866, 19AM17869, 18GM07436, 18GM07437, 18GM07438, 18GM07445, 18GM07469, 18GM07522, 18GM07533, 18KM03144, 18KM03147, 18KM03148, 18KM23654, 18KM23655, 18KM23662, 18MM08650, 18MM08663, 18MM08676, 18MM08678, 18MM08683, 18MM08695, 18MM08697, 18MM08724, 19AM17823, 19AM17833, 19AM17837, 19AM17845, 18MM08650A, 18MM08663A, 19AM17845A, 19AM17833A, 19AM17837A 71331856, Lot Numbers: 18JM15947, 18MM12475, 18JM15950, 18KM04251, 18HM19101, 18JM15940, 18KM04254, 18HM19123, 18KM15773, 18JM15949, 18JM15949A, 18LM18546, 18HM19116, 18HM19117, 18JM15941, 18KM04226, 18KM04250, 18KM04252, 18KM04253, 18KM13646, 18KM17025, 18KM17026, 18KM17029, 18KM17031, 18KM17032, 18LM18544, 18LM18550, 18MM12424, 18MM12426, 18MM12428, 18MM15587, 18MM15611, 18LM05390, 18KM17031A, 18LM18550A 71331858, Lot Numbers: 19AM03504, 19AM03511 71331860, Lot Numbers: 18JM10154, 18JM10154A
- 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:
- Smith & Nephew, Inc.
- Reason for Recall:
- A manufacturing error resulted in out of specification R3 Acetabular Shells
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.
Product Codes/Lot Numbers:
71331842, Lot Numbers: 18HM20691, 18LM09819, 18KM1572 71331848, Lot Numbers: 18HM01685, 19AM15804, 19AM15805, 19AM15809, 19AM15828, 19AM15829 71331850, Lot Numbers: 18LM00667, 18LM00668, 18LM00670, 18LM00671, 18LM00702, 18LM00668A, 18LM00671A 71331852, Lot Numbers: 19EM10292, 18KM20315, 18KM15739, 18KM20284, 18LM17941, 18LM02317, 18KM00744, 18KM00775, 18KM00779, 18KM00833, 18KM06667, 18KM06675, 18KM06676, 18KM06680, 18KM06681, 18KM06682, 18KM13594, 18KM13632, 18KM15736, 18KM15737, 18KM15738, 18KM20281, 18KM20289, 18KM20291, 18KM20292, 18KM24785, 18KM24792, 18KM24795, 18KM24805, 18LM02315, 18LM02337, 18LM17942, 18LM17946, 18KM20281A, 18LM07653, 18KM15736A, 18LM14077, 18KM24785A, 18KM20293A 71331854, Lot Numbers: 18JM13875, 18mm08723, 18JM13874, 19AM17866, 19AM17869, 18GM07436, 18GM07437, 18GM07438, 18GM07445, 18GM07469, 18GM07522, 18GM07533, 18KM03144, 18KM03147, 18KM03148, 18KM23654, 18KM23655, 18KM23662, 18MM08650, 18MM08663, 18MM08676, 18MM08678, 18MM08683, 18MM08695, 18MM08697, 18MM08724, 19AM17823, 19AM17833, 19AM17837, 19AM17845, 18MM08650A, 18MM08663A, 19AM17845A, 19AM17833A, 19AM17837A 71331856, Lot Numbers: 18JM15947, 18MM12475, 18JM15950, 18KM04251, 18HM19101, 18JM15940, 18KM04254, 18HM19123, 18KM15773, 18JM15949, 18JM15949A, 18LM18546, 18HM19116, 18HM19117, 18JM15941, 18KM04226, 18KM04250, 18KM04252, 18KM04253, 18KM13646, 18KM17025, 18KM17026, 18KM17029, 18KM17031, 18KM17032, 18LM18544, 18LM18550, 18MM12424, 18MM12426, 18MM12428, 18MM15587, 18MM15611, 18LM05390, 18KM17031A, 18LM18550A 71331858, Lot Numbers: 19AM03504, 19AM03511 71331860, Lot Numbers: 18JM10154, 18JM10154A
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2331-2020
Related Recalls
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Smith & Nephew
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
The Bipolar assembly contains an oversized Retainer Ring.