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High RiskFDAfda-Z-2177-2018CHEMICAL EXPOSURE

Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 2...

Units Affected
16
Recall Date
May 18, 2018
Issuing Agency
Hazard
Chemical Exposure

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2177-2018.

One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2177-2018.

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-2177-2018.

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: Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 2.... The notice was published on May 18, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 16 units are potentially affected.