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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Product Detail

Product Description Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile
Recall Number Z-0964-2014
Classification Class II
Code Info Catalog no. 2124-1400 All lots
Product Distributed Qty 211 units
Reason For Recall Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.

Event Detail

Event Id 67234
Product Type Devices
Status Ongoing
Recalling Firm Stryker Howmedica Osteonics Corp.
City Mahwah
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern IL MA, MN, ND, OR, & PA