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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Howmedica Osteonics Corp.

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 Class 2 Recall
Stryker Howmedica Osteonics Corp.
see related information
Date Posted March 08, 2013
Recall Status1 Open
Recall Number Z-0919-2013
Recall Event ID 64306
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
Code Information Catalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated December 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (201) 972-2100 for questions regarding this issue.
Quantity in Commerce 48 units
Distribution Nationwide Distribution.
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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