Recall Z-0170-06 ยท HWC Screw, Fixation, Bone
Stryker Howmedica Osteonics Corp.
Gamma System, Cross Screw, Self-Tapping (Cleared under Grosse and Kempf Locking Nail System)
| Date | Nov 18, 2005 (initiated Oct 4, 2005) |
| Status | Terminated |
| Reason | Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier. |
| Root cause | Other |
| Action | The product recall will extend to all branches.agencies and hospitals that have received the product. |
| Quantity | 34,839 units |
| Distribution | nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.