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 an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. It was sold nationwide.
Why it was recalled
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
What's recalled
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
Quantity: 2
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-2883-2026
- Source
- U.S. Food and Drug Administration
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