Recall Z-0964-2014 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile
| Date | Feb 10, 2014 (initiated Nov 20, 2013) |
| Status | Terminated |
| Reason | Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle. |
| Root cause | Process design |
| Action | Stryker Orthopaedics sent notification letters and acknowledgement forms via Fed Ex as follows: Branches-11/20/2013 Hospital Risk Manager - 11/21/2013 |
| Quantity | 211 units |
| Distribution | IL MA, MN, ND, OR, & PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.