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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Detail

Product Description 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.
Recall Number Z-2187-2012
Classification Class II
Code Info Part number 02.03155.026, lot 2649941
Product Distributed Qty 24 to US Distributor with 7 further distributed
Reason For Recall 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.

Event Detail

Event Id 62499
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ.