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High RiskFDAfda-Z-0596-2018CRASH

Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implan...

Units Affected
1,275
Recall Date
August 28, 2017
Issuing Agency
Hazard
Crash

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0596-2018.

Potential for the Persona Partial Knee Impactor Pad to fracture.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0596-2018.

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 Biomet, 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-0596-2018.

Zimmer Biomet, Inc.

FDA

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Zimmer Biomet, Inc. Recall FAQ

Zimmer Biomet, Inc. is the subject of a medical implants safety report: Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implan.... The notice was published on August 28, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 1,275 units are potentially affected.