Recall Z-0583-2014 ยท HWA Impactor
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
| Date | Dec 27, 2013 (initiated Sep 30, 2013) |
| Status | Terminated |
| Reason | Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments. |
| Root cause | Device Design |
| Action | Stryker sent an Urgent Medical Device Correction letter dated October 1, 2013 to all affected customers via Fed Ex. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and fax the attached Product Correction Acknowledgement form to 855-251-3635. |
| Quantity | 1,024 units |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.