Recall Z-2007-2008 ยท HWC Screw, Fixation, Bone
Stryker Howmedica Osteonics Corp.
6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA, A Subsidiary of Stryker Corp., Made in USA; Catalog Number: 2030-6525-1 The Omnifit bone screws are intended to augment the fixation of compatible acetabular cups.
| Date | Sep 22, 2008 (initiated Dec 20, 2005) |
| Status | Terminated |
| Reason | The firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length. |
| Root cause | Labeling mix-ups |
| Action | The recalling firm sent notification letters and Product Accountability Forms via Fed Ex with return receipt on December 20, 2005. The notification letter described the problem, and asked customers to inventory and quarantine the affected product. Customers were told to return the affected product to Stryker. Contact Stryker at 1-201-831-5825 for assistance. |
| Quantity | 29 units |
| Distribution | nationwide |
| FDA record | Open on fda.gov |