Knee Prosthesis Trial Recall for Manufacturing Defect
United Orthopedic Corp. recalls U2 Total Knee System PSA Box Trial due to a manufacturing defect in a component screw that prevents proper assembly of the stem trial.
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: This is a risk-of-harm medical device with a manufacturing defect that could cause surgical complications, but no injuries have been reported. FDA Class II classification without reported hospitalizations supports a High severity rating.
Plain-English summary
United Orthopedic Corp. is recalling its U2 Total Knee System PSA Box Trial, left and right, model numbers 9323-5511 through 9323-5516 and 9323-5521 through 9323-5526. These are reusable knee femur prosthesis trials. The recall is due to an incomplete process of the component screw by a subcontractor, which prevents the properly assembling of the stem trial. This is an FDA Class II recall distributed nationwide in the states of Texas and Michigan. Healthcare facilities and surgeons should discontinue use of the affected products and contact the manufacturer for replacement options. Patients scheduled for knee surgery should discuss alternatives with their surgeon.
The recalled product
- Product
- 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
- Manufacturer
- United Orthopedic Corp.
- Affected units
- 2
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 (20)
- Product Number
- UDI-DI Code
- Lot Code: Product Number 9323-5511
- UDI-DI 04719886906929
- Lot number 25FB54 Product Number 9323-5512
- UDI-DI 04719886906936
- Lot number 25FB55 Product Number 9323-5513
- UDI-DI 04719886906943
- Lot number 25FB56 Product Number 9323-5514
- UDI-DI 04719886906950
- Lot number 25FB57 Product Number 9323-5515
- UDI-DI 04719886906967
- Lot number 25FB58 Product Number 9323-5516
- UDI-DI 04719886906424
- Lot number 25FB59 Product Number 9323-5521
- UDI-DI 04719886906974
- Lot number 25FB29 Product Number 9323-5522
- UDI-DI 04719886906981
- Lot number 25FB30 Product Number 9323-5523
- UDI-DI 04719886906998
Distribution
Part of a larger recall action
This product is one of 4 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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