United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: Femoral offs
See all recalls from United Orthopedic Corp. →Recalled Product
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Hazard / Issue
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Brand Name: U2 Total →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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