FDAApril 22, 2020device
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A manufacturing error resulted in out of specification R3 Acetabular Shells
What to do
FDA enforcement status: Ongoing
Brands named
smith nephewsmithsmith nephew
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDATRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 717608162026-03-16
- FDABIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.2025-11-24
- CPSCAgro Superior Group Recalls Oliver & Smith Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violation of Federal Standard for Mattress Flammability2025-06-12
- USDA FSISSmith Packing, LLC Recalls Sausage and Sliced Meat and Poultry Products Due to Sodium Nitrite Levels in Excess of Regulatory Limit2025-04-29
- FDACADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL,...2025-04-10
- FDACADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-08 21-2120-0102-12 21-2120-0102-13 ...2025-04-10
- FDACADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-5...2025-04-10
- FDACADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR CLINICAL EVALUATIO...2025-04-10
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