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High RiskFDAfda-Z-2187-2012STERILITY ISSUE

The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporar...

Units Affected
24
Recall Date
July 13, 2012
Issuing Agency
Hazard
Sterility Issue

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2187-2012.

Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2187-2012.

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-2187-2012.

Zimmer, Inc.

FDA

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Zimmer, Inc. Recall FAQ

Zimmer, Inc. is the subject of a medical implants safety report: The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporar.... The notice was published on July 13, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 24 units are potentially affected.