Recall Z-0794-2010 ยท HTO Reamer
Stryker Howmedica Osteonics Corp.
Navigation Reamer T-handle; Non Sterile; Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430. Intended for use in orthopaedic surgery to interface with various cutting instruments and drivers.
| Date | Feb 17, 2010 (initiated Aug 8, 2005) |
| Status | Terminated |
| Reason | Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly. |
| Root cause | Device Design |
| Action | Stryker Orthopaedics issued notification dated August 8, 2005 via Federal Express. Consignees were informed of the affected product and necessary steps to take for product replacement. For further information, contact Stryker at (201) 831-5825. |
| Quantity | 22 |
| Distribution | Worldwide Distribution -- United States, Germany, The Netherlands, Spain, Italy, Switzerland, Poland, Romania, South Africa, England, Columbia, Venezuela, Japan and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.