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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics Rim Impactor Tip

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 Class 2 Recall
Stryker Orthopaedics Rim Impactor Tip
see related information
Date Posted December 27, 2013
Recall Status1 Open
Recall Number Z-0582-2014
Recall Event ID 66909
Product Classification Impactor - Product Code HWA
Product Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
Code Information Catalog number 12350-013 all lot codes
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Ms. Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall
Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
FDA Determined
Cause 2
DESIGN: Device Design
Action Stryker sent an Urgent Medical Device Correction letter dated October 1, 2013 to all affected customers via Fed Ex. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and fax the attached Product Correction Acknowledgement form to 855-251-3635.
Quantity in Commerce 1,690 units
Distribution USA 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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