United Orthopedic Recalls U2 Total Knee System Femoral Offset Bushings
United Orthopedic Corp. is recalling U2 Total Knee System femoral offset bushings due to incorrect engraved numbering that could cause incorrect implant orientation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could result in incorrect implant orientation, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
United Orthopedic Corp. is recalling three units of the U2 Total Knee System femoral offset bushing, 2mm and 6mm (Model/Catalog Number 9323-5312). The recall is due to a design issue that resulted in incorrect engraved numbering on the implant. This defect could lead to the incorrect orientation of the implant during surgical use.
The affected units were distributed nationwide in the United States, specifically in the states of Texas and Michigan. The specific lot number for the recalled items is 25FC64, with UDI-DI 04719886908077.
Healthcare providers and facilities should stop using the affected bushings immediately and contact United Orthopedic Corp. for further instructions on the recall process.
The recalled product
- Product
- 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
- Manufacturer
- United Orthopedic Corp.
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: Product number 9323-5312
- UDI-DI 04719886908077
- Lot number 25FC64
Distribution
Part of a larger recall action
This product is one of 2 recalled by United Orthopedic Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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