United Orthopedic U2 knee system bushing recalled over engraving error
United Orthopedic Corp. is recalling three femoral offset bushings (0mm and 4mm, catalog 9323-5310, lot 25FC58) from its U2 Total Knee System. The implant's engraved numbering may be incorrect, which could lead to it being placed in the wrong orientation. The units were distributed in Texas and Michigan, and no injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check the catalog number 9323-5310 and lot number 25FC58 on any bushings in your inventory.
- Set aside any affected bushings and do not use them in procedures.
- Contact United Orthopedic Corp. for instructions on returning or disposing of the affected units.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 3
- Illnesses reported
- None reported
- Manufactured in
- No. 16 Luke 1st Rd., Luzhu Dist., Kaohsiung, Taiwan
- Classification
- Class II
- Recall number
- Z-2897-2026
In the FDA's words
- Description
- 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 Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58 Distribution: US Nationwide distribution in the states of Texas and Michigan. Affected quantity: 3
- Hazard
- Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
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