FDAJune 27, 2022device
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
What to do
FDA enforcement status: Terminated
Brands named
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UPCs
0359601020635003596010206268
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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