Recall Z-1690-2008 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
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.
| Date | Sep 20, 2008 (initiated Mar 18, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 739 units in US; 1213 units internationally |
| Distribution | Products were distributed worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.