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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 Initiated by Firm November 20, 2013
Date Posted February 10, 2014
Recall Status1 Terminated 3 on October 13, 2016
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 NJ 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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