Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1170-2017.
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1170-2017.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1170-2017.
Biomet U.K., Ltd.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Biomet U.k., Ltd. Recall FAQ
Biomet U.k., Ltd. is the subject of a medical devices safety report: Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System. The notice was published on January 5, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 72 units are potentially affected.