FDASeptember 11, 2025device
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-004...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
What to do
FDA enforcement status: Ongoing
Brands named
theken companiestheken
UPCs
008161270294310081612702944800816127029455008161270294620081612702947900816127029486008161270294930081612702950900816127029516008161270295230081612702953000816127029547
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAUPC 25139500000 Cake Cakerie Strawberry Shortcake Triangle. This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.2026-05-06
- FDAUPC 25491700000 Cake Pav Chocolate Lady Madeleines Strawberry. This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.2026-05-06
- FDAUPC 29251100000 Ready Meals TUNA SALAD & PEPPER JACK CHEESE SNACKER This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.2026-05-06
- FDAUPC 28848900000 Cake Yellow Fudge Pecan 1/2 8IN This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.2026-05-06
- FDAUPC 28832500000 Cake Yellow Caramel Pecan 1/2 8IN UPC 28831600000 Cake Yellow Caramel Pecan 2-Layer These are Albertson's store-made items and sold by unit at point of sale with grocery store's scale labels.2026-05-06
- FDAUPC 22679400000 CAKE CRAVIN CARROT 8IN 1-layer This is Albertson's store-made item and is sold by each unit at point of sale with grocery store's scale label.2026-05-06
- FDAUPC 24144500000 Ready Meals PEANUT BUTTER CHOCOLATE CHIP BAR With PRETZEL This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.2026-05-06
- FDAUPC 25811100000 CAKE RASPBERRY MOON 8IN 2-layer. This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.2026-05-06
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