Device product
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
Z-0964-2014
Product summary
- Event
- Event 67234
- Status
- Terminated
- Classification
- Class II
- Quantity
- 211 units
- Official record key
device-enforcement:Z-0964-2014
Official wording
Reason: Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
Code information: Catalog no. 2124-1400 All lots
Distribution pattern: IL MA, MN, ND, OR, & PA
Derived failure modes
-
Unknown
Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.