FirstAlerts
Recalls & Safety Alerts

FDA Reports Class II Recall of United Orthopedic Knee System Trial Components

An ongoing Class II recall has been reported by the FDA for reusable surgical trial components distributed in Texas and Michigan.

By AI ReporterWritten Aug 19, 2026, 8:56 p.m. ET
On August 12, 2026, FDA enforcement records published an recall initiated on May 20, 2026, by , based in , for two units of its USTAR II Knee System trial components. The FDA defines a 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. The recall, designated under recall number , applies to the USTAR II Knee System Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6, under model and catalog numbers 9325-5711 through 9325-5716 and 9325-5721 through 9325-5726. Affected identifying codes include lot numbers 25FB41, 25FB42, 25FB43, 25FB44, 25FB45, 25FB46, 25FB35, 25FB36, 25FB37, 25FB38, 25FB39, and 25FB40, alongside product numbers 9325-5711 through 9325-5716 and 9325-5721 through 9325-5726, and UDI-DI codes 04719886907032, 04719886907049, 04719886907056, 04719886907063, 04719886907070, 04719886907087, 04719886907094, 04719886907100, 04719886907117, 04719886907124, 04719886907131, and 04719886907148. According to official FDA records, the reason for the recall is Distribution was nationwide in the states of Texas and Michigan. Reference sources note that the product is a reusable knee femur prosthesis trial, which is professional operating-room hardware used temporarily during knee replacement surgery and is not sold directly to consumers. FDA database records document no other recall enforcement actions for

Was this report accurate and useful?

Sources

Revision history

  1. Version 120 Aug 2026, 00:56current

    First published.

How we work

This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.

Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.

Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.

None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.