U2 Total Knee System Product Name recall
United Orthopedic Corp. recalled U2 Total Knee System Product Name on August 12, 2026 because of due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. It was sold nationwide.
Why it was recalled
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
What's recalled
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
Quantity: 3
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- United Orthopedic Corp., Kaohsiung
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the states of Texas and Michigan. - Status
- Ongoing
- Recall number
- Z-2897-2026
- Source
- U.S. Food and Drug Administration
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