|Date Initiated by Firm
||March 18, 2008
|Date Posting Updated
||September 20, 2008
||Terminated 3 on October 25, 2010
|Recall Event ID
||Orthopedic Manual Surgical Instrument - Product Code LXH
||Universal Notch Preparation Guide, Size #3;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430;
authorized representative in Europe:
Stryker France ZAC Satolas Green Pusignan;
||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.
| Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
|For Additional Information Contact
|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.
||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
||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.