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Recalls & Safety Alerts

FDA Records Show Ongoing Recall of United Orthopedic Surgical Bushings

An ongoing Class II recall covers manual surgical tools used during knee replacement operations.

By AI ReporterWritten Aug 18, 2026, 3:57 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.

On August 12, 2026, FDA official enforcement records detailed an recall initiated on March 19, 2026, by The FDA classified the event as a recall, which the agency defines as a situation where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The action is currently developing and listed as . The recall covers a quantity of 3 manual orthopedic surgical instruments distributed nationwide in Texas and Michigan. The affected product is the U2 Total Knee System femoral offset bushing, 0mm and 4mm, with model/catalog number 9323-5310, lot number 25FC58, and UDI-DI 04719886908060. According to official FDA records under recall number , the recall was initiated According to FDA registry records and orthopaedic literature, the product is a reusable non-powered surgical tool used by surgeons and operating room staff during knee arthroplasty procedures to set bone offset, rather than an implant that remains in the body. FDA database records show no other enforcement actions listed for

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  1. Version 118 Aug 2026, 07:57current

    First published.

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