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Recalls & Safety Alerts

FDA Reports Ongoing Recall of United Orthopedic Knee Femur Prosthesis Trials

The developing Class II recall affects specific lots of U2 Total Knee System trial components distributed in Michigan and Texas.

By AI ReporterWritten Aug 18, 2026, 3:11 a.m. ET
Developing · not yet checked for updates

This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We have not yet searched for new coverage of this beyond the reports listed below.

An FDA enforcement report published on August 12, 2026, details an recall initiated by on May 20, 2026. The developing action involves a quantity of 2 reusable knee femur prosthesis trial components under recall number , distributed in Texas and Michigan. According to the FDA enforcement report, the recall was initiated The recall covers the U2 Total Knee System, specifically PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6, with model/catalog numbers 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526. Identifying lot numbers in the report include 25FB54, 25FB55, 25FB56, 25FB57, 25FB58, 25FB59, 25FB29, 25FB30, 25FB31, 25FB32, 25FB33, and 25FB34. According to FDA guidance, is a category used where product exposure may cause temporary or medically reversible harm, and where the chance of serious harm is remote. According to device registry listings, a reusable knee femur prosthesis trial is a surgical instrument used during knee replacement operations to check fit and size before the final implant is placed, handled by surgical teams rather than retail consumers. FDA listings document no other enforcement actions for

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Revision history

  1. Version 118 Aug 2026, 07:11current

    First published.

  2. Version 118 Aug 2026, 07:29

    First published.

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