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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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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
Distribution Pattern IL MA, MN, ND, OR, & PA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Catalog no. 2124-1400 All lots Class II Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle. 211 units Z-0964-2014