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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics

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 Class 2 Device Recall Stryker Orthopaedics see related information
Date Posted February 10, 2014
Recall Status1 Open
Recall Number Z-0964-2014
Recall Event ID 67234
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product 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
Code Information Catalog no. 2124-1400
All lots
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Ms. Colleen O'Meara
Manufacturer Reason
for Recall
Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
FDA Determined
Cause 2
Process design
Action Stryker Orthopaedics sent notification letters and acknowledgement forms via Fed Ex as follows: Branches-11/20/2013 Hospital Risk Manager - 11/21/2013
Quantity in Commerce 211 units
Distribution IL MA, MN, ND, OR, & PA
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.