Product Wiki · Recalls · U.S. FDA — Device Enforcement

The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026… — recall Z-2187-2012

U.S. FDA — Device Enforcement · United States · 2012-07-13 · Class II

As described by U.S. FDA — Device Enforcement: The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2187-2012
Date of alert
2012-07-13
Country / jurisdiction
United States
Risk level
Class II
Notice type
recall
Brand
Zimmer, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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