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High RiskFDAfda-Z-2035-2014STERILITY ISSUE

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femora...

Units Affected
315
Recall Date
May 23, 2014
Issuing Agency
Hazard
Sterility Issue

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2035-2014.

Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2035-2014.

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-2035-2014.

Zimmer, Inc.

FDA

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Zimmer, Inc. Recall FAQ

Zimmer, Inc. is the subject of a medical implants safety report: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femora.... The notice was published on May 23, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 315 units are potentially affected.