Universal Notch Preparation Guide, Size #3; Non Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430;
FDA device recall Z-1690-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 739 units in US; 1213 units internationally
- Distribution
- Products were distributed worldwide.
- Date initiated
- 2008-03-18
- Date posted
- 2008-09-20
- Date terminated
- 2010-10-25
- Location
- Mahwah, NJ
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