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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics

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 Class 2 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 non-sterile
Code Information Catalog no. 2124-1400 All lots
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Ms. Colleen O'Meara
201-972-2100
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
OTHER/UNDETERMINED: Pending
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.
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