United Orthopedic U2 Knee Implant Bushings Recalled Over Engraving Design Issue
United Orthopedic Corp. is recalling three Femoral offset bushing components of the U2 Total Knee System due to a design issue causing incorrect engraved numbering that could lead to incorrect implant orientation during surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a medical device with a design issue that could affect implant orientation during surgery. Per the rubric, FDA Class II recalls with potential for injury or harm are classified as Severe (score 4).
Plain-English summary
United Orthopedic Corp. is recalling three units of the Femoral offset bushing, 0mm and 4mm components used in the U2 Total Knee System. The recall is due to a design issue that results in incorrect engraved numbering on the implant.
The incorrect engraved numbering could cause surgeons to misorient the implant during surgery, potentially affecting the performance or safety of the knee replacement procedure.
The affected product is identified by model/catalog number 9323-5310 and lot number 25FC58. Distribution was limited to the states of Texas and Michigan.
Healthcare providers and facilities that received the affected devices should follow their internal procedures for recalled medical devices and contact United Orthopedic Corp. for replacement or corrective action.
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
- Manufacturer
- United Orthopedic Corp.
- Hazard
- 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 9323-5310
- UDI-DI 04719886908060
- Lot number 25FC58
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.
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