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High RiskFDAfda-Z-1046-2016OTHER

M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093

Units Affected
9
Recall Date
February 11, 2016
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1046-2016.

Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1046-2016.

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-1046-2016.

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: M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093. The notice was published on February 11, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 9 units are potentially affected.