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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 Device Recall Stryker Orthopaedics Rim Impactor Tip see related information
Date Initiated by Firm September 30, 2013
Date Posted December 27, 2013
Recall Status1 Open3, Classified
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 NJ 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
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 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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