6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive
FDA device recall Z-2007-2008 · posted 2008-09-22 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 29 units
- Distribution
- nationwide
- Date initiated
- 2005-12-20
- Date posted
- 2008-09-22
- Date terminated
- 2008-09-23
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS (K894124) | Osteonics Corp. | 1989-09-11 |
| OMNIFIT BONE SCREW (K873251) | Osteonics Corp. | 1987-09-18 |