FDA Reports Closure of United Orthopedic Corp. Surgical Adaptor Recall

The FDA has closed a Class II recall involving two femoral valgus adaptors used in knee-replacement surgery sets.

2 reports on this incident · first at Aug 18, 2026, 5:56 a.m. ET

By AI ReporterWritten Aug 18, 2026, 7:59 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.

The U.S. Food and Drug Administration (FDA) reported on August 12, 2026, that a recall initiated on May 20, 2026, by has been closed, meaning the agency considers the recall action carried out. The recall covered two units of femoral valgus adaptors distributed to surgical facilities in Texas and Michigan under recall number . The affected items are left and right femoral valgus adaptors for the U2 Total Knee System, catalog numbers 9323-5333 and 9323-5334. The specific identifying codes are product number 9323-5333 with UDI-DI 04719886908084 and lot number 25FB50, alongside product number 9323-5334 with UDI-DI 04719886908091 and lot number 25FB51. According to the official FDA enforcement report, the recall was initiated due to incomplete processing of a component screw by a subcontractor, which prevented proper assembly of the stem trail. The FDA defines a classification as a situation where use of or exposure to a recall product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA registry records and product clearance documentation specify that the instrument is a reusable, hand-held manual orthopedic tool used by surgical staff to align femoral cuts during knee arthroplasty, rather than an implanted device. FDA database records reflect no other enforcement actions for

Earlier reports

Aug 18, 2026, 5:56 a.m. ETFirst report
FDA Reports Ongoing Recall of Surgical Adaptors by United Orthopedic Corp.
On August 12, 2026, the FDA published an enforcement report detailing an ongoing Class II recall initiated on May 20, 2026, by United Orthopedic Corp. The recall, registered under recall number Z-2885-2026, covers a quantity of 2 units distributed in Texas and Michigan.
The recalled products are manual orthopedic surgical instruments from the U2 Total Knee System, identified as left and right femoral valgus adaptors. The recall covers model/catalog number 9323-5333 (UDI-DI 04719886908084, lot number 25FB50) and model/catalog number 9323-5334 (UDI-DI 04719886908091, lot number 25FB51). According to the FDA enforcement report, the action was taken due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
According to federal regulatory and patent records, a femoral valgus adaptor is a piece of reusable operating-room hardware supplied to surgical facilities to help set the thigh bone alignment angle during knee replacement surgery. The FDA defines a Class II recall as 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. FDA database records reflect no other enforcement actions for United Orthopedic Corp.

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Version 118 Aug 2026, 09:56current
First published.
Version 118 Aug 2026, 11:59current
First published.

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