United StatesU2 Total Knee System femoral offset bushings — sizes 0mm and 4mm (catalog 9323‑5310, UDI‑DI 04719886908060, lot 25FC58) and 2mm and 6mm (catalog 9323‑5312, UDI‑DI 04719886908077, lot 25FC64) — are being recalled; three units were distributed in Texas and Michigan. The recall was issued because a design issue can cause incorrect engraved numbering on the implant, which could result in incorrect implant orientation.
What's being 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
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Recalling firm: United Orthopedic Corp., Kaohsiung, Taiwan.
How to identify it
Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58 Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64
The hazard
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of Texas and Michigan.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)