High RiskFDAfda-Z-1052-2015STERILITY ISSUE

Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Pro...

Q: What is being recalled?

Zimmer, Inc. is the subject of a medical implants safety report: Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Pro.... The notice was published on December 11, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 67,963 units are potentially affected.

Q: Why was this product recalled?

This recall was issued in connection with a sterility issue concern. The full description above contains the FDA's official wording about the defect, affected lots, and impacted distribution — read it carefully.

Q: What should I do if I have this product?

Stop using the product. Check the lot number, model number, or sell-by date against the recall notice above. Then contact Zimmer, Inc. or the retailer where you purchased it to request a refund, replacement, or repair. The official FDA page has the most current instructions: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.

Q: Is a refund or replacement free?

Yes. Under federal recall procedures, consumers are entitled to a remedy at no cost — typically a full refund, free replacement, or free repair. There is generally no expiration on safety recalls. Keep your receipt if possible, but most agencies require remedies even without proof of purchase.

Q: Has anyone been hurt by this product?

Injury and incident reports are part of the official recall announcement above. If you or a member of your household has been harmed by this product, report the incident to FDA at https://www.fda.gov/safety/report-problem-fda. Reports help the agency identify ongoing risks and pursue follow-up enforcement.

Q: Where can I get more information?

The U.S. Food and Drug Administration (FDA) is the authoritative source for this recall. Visit https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts for the complete recall notice, lot codes, and the manufacturer's contact information.

Q: Is this an FDA food or cosmetic recall?

This recall is in the FDA's jurisdiction and may cover food, dietary supplements, cosmetics, or related products. Follow the FDA's official guidance in the notice above. If you have consumed the product and are concerned about your health, contact a healthcare provider.

Brand

Zimmer, Inc.

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1052-2015.

Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, TASP shims must be manually cleaned and inspected per product insert, 87-6203-991-22.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1052-2015.

Recall terminated by FDA.

✅ What you should do

Stop using the product if you own it.
Check the model number, lot code, or sell-by date against the recall notice above.
Contact Zimmer, Inc. or the retailer where you bought it for a refund, replacement, or repair.
For the most current official instructions, visit the FDA recall page.
If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1052-2015.

Zimmer, Inc.

Official Source

FDA Recalls

U.S. Food and Drug Administration

Report an Incident

File a Complaint

Reports inform future enforcement

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

Visit FDA.gov →

📣 Report a food, supplement, or cosmetic problem to the FDA

If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

How to report to FDA →File a report at FDA →

Zimmer, Inc. Recall FAQ

What is being recalled?

Zimmer, Inc. is the subject of a medical implants safety report: Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Pro.... The notice was published on December 11, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 67,963 units are potentially affected.

Why was this product recalled?

What should I do if I have this product?

Is a refund or replacement free?

Has anyone been hurt by this product?

Where can I get more information?

Is this an FDA food or cosmetic recall?

Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Pro...

FDA Recall Notice

Corrective Action (per FDA)

✅ What you should do

Consumer Contact (per FDA)

About the U.S. Food and Drug Administration

📣 Report a food, supplement, or cosmetic problem to the FDA

Zimmer, Inc. Recall FAQ

Other recalls from Zimmer, Inc.

Other medical implants recalls