FDAApril 22, 2020device
smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 71331962 64MM 71331964 68MM 713...
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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