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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 18, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on October 25, 2010
Recall Number Z-1690-2008
Recall Event ID 47519
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Universal Notch Preparation Guide, Size #3;
Non Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430;
authorized representative in Europe:
Stryker France ZAC Satolas Green Pusignan;
Cedex, France.
Code Information All lots manufactured since 1998. Catalog Number 7650-3363. Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430; authorized representative in Europe: Stryker France ZAC Satolas Green Pusignan; Cedex, France.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Rita Intorella
201-831-6413
Manufacturer Reason
for Recall		 Discovery of the potential for Pin and Punch interference of the Size 3 Scorpio Notch Preparation Guide that may result in damage to bone if a user aggressively attempts to seat an obstructed punch.
FDA Determined
Cause 2		 Device Design
Action Urgent Product Correction notification letters were sent via Federal Express, return receipt to all users on March 18, 2008. Questions should be directed to Rita Intorella, Divisional Regulatory Reporting at (201) 831-5825.
Quantity in Commerce 739 units in US; 1213 units internationally
Distribution Products were distributed worldwide.
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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