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High RiskFDAfda-Z-0123-2015STERILITY ISSUE

The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedur...

Units Affected
618
Recall Date
October 7, 2014
Issuing Agency
Hazard
Sterility Issue

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0123-2015.

Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0123-2015.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Zimmer, Inc. or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. 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-0123-2015.

Zimmer, Inc.

FDA

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Zimmer, Inc. Recall FAQ

Zimmer, Inc. is the subject of a medical implants safety report: The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedur.... The notice was published on October 7, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 618 units are potentially affected.