Recall Z-0330-2011 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker Howmedica Osteonics Corp.
External Compression Device; 1 unit per package Stryker Trauma GmbH; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 Active Apposition/compression is achieved by threading the External Compression Device into the Nail holding Screw. While being threaded into the Nail Holding Screw the tip of the External Compression Device will contact the (shaft screw(cross screw)
| Date | Nov 9, 2010 (initiated Aug 30, 2010) |
| Status | Terminated |
| Reason | Variations in the outer diameter of the shaft of the External Compression Device and the inner diameter of the Nail Holding Screw may make assembly of these 2 instruments not possible. |
| Root cause | Other |
| Action | Stryker sent Recall notification letters by Federal Express on September 9, 2010 to all Stryker branches/agencies and Risk Managers, Chief of Orthopaedics of affected hospitals and Surgeons on September 10, 2010, that used the product. The letter identified the product, the problem, and the action that customers should take. Customers were instructed to: Examine their inventory and hospital locations to identify the affected product and return it to their branch or agency warehouse for reconciliation. Reconcile all product on the attached Product Recall Acknowledgment Form and fax a copy to |
| Quantity | 11 |
| Distribution | Nationwide Distribution including AZ, CA, CO, FL, GA, IL, KY, MD, OH, OK, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.