Recall Z-0719-04 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics
Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions.
| Date | Jul 20, 2004 (initiated Feb 10, 2004) |
| Status | Terminated |
| Reason | The Cylindrical Distal Extensions were incorrectly coded and packaged. |
| Root cause | Other |
| Action | Stryker Orthopaedics sent product recall letters to the Branch/Agency involved on 2/10/2004 via FedEx. International distributor was sent notification on 2/10/2004. |
| Quantity | 20 |
| Distribution | The 9 units were sent out to 2 US branch/agents and one international distributor. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.