Recall Z-2080-2008 ยท JEC Component, Traction, Invasive
Stryker Howmedica Osteonics Corp.
Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.
| Date | Sep 16, 2008 (initiated Aug 17, 2005) |
| Status | Terminated |
| Reason | Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector. |
| Root cause | Device Design |
| Action | Letters were sent to Stryker branches and hospitals on August 17, 2005. If you have questions concerning this recall, contact Rita Intorrella at 201-831-5825 or Katherine Collins at 201-831-5025. |
| Quantity | 105 units |
| Distribution | The product was distributed to 23 Stryker Branches, 25 hospitals and 1 government hospital nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971755 | HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM Howmedica Corp., Jul 17, 1997 |