United Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System
United Orthopedic Corp. is recalling specific femoral valgus offset adaptors used in the U2 Total Knee System due to a manufacturing defect in a component screw.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 product is a medical device with a high-risk hazard (improper assembly of a surgical component) where injury has not yet been reported.
Plain-English summary
United Orthopedic Corp. is recalling femoral valgus offset adaptors (2mm, 4mm, and 6mm sizes; left and right) used in the U2 Total Knee System. The affected products include model/catalog numbers 9323-5335, 9323-5337, 9323-5339, 9323-5336, 9323-5338, and 9323-5340.
The recall was initiated because an incomplete process of a component screw by a subcontractor prevents the proper assembly of the stem trial. This manufacturing issue affects specific lots, including 25FB64, 25FB48, 25FB52, 25FB65, 25FB49, and 25FB53.
This recall is distributed nationwide in the states of Texas and Michigan. Healthcare providers and users should follow manufacturer instructions regarding these components.
The recalled product
- Product
- Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product…
- 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 (15)
- Product Number
- UDI-DI Code
- Lot Code: Product number 9323-5335
- UDI-DI 04719886906554
- Lot number 25FB64 Product number 9323-5337
- UDI-DI 04719886906578
- Lot number 25FB48 Product number 9323-5339
- UDI-DI 04719886906592
- Lot number 25FB52 Product number 9323-5336
- UDI-DI 04719886906561
- Lot number 25FB65 Product number 9323-5338
- UDI-DI 04719886906585
- Lot number 25FB49 Product number 9323-5340
- UDI-DI 04719886906608
- Lot number 25FB53
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.
See all 4 products in this recall →Related recalls
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