FDA Device recall Z-0964-2014
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive…
- FDA Device
- Class II
- terminated
- Published 2014-02-19
On 2014-02-19 the FDA classified a Class II recall of Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive… by Stryker Howmedica Osteonics, citing stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0964-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-20 |
| Published | 2014-02-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | IL, MA, MN, ND, OR, PA |
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
Reason
Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
Identifiers
| code_info | Catalog no. 2124-1400 All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0964-2014%22
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