FDAJuly 22, 2020device
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over th...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Multiple lots being recalled due to a product design issue
What to do
FDA enforcement status: Ongoing
Brands named
smith nephew orthopaedics agsmithsmith nephew
UPCs
00885556535493
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
- FDABEAR Implant. Model Number: 1000.2025-12-31
- 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 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 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 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
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