Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1… — Class II medical device recall Z-0964-2014
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2014-02-19, distributed in IL, MA, MN, ND, OR, PA. Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of t
| Recall number | Z-0964-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2013-11-20 |
| Classified | 2014-02-10 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2016-10-13 |
| Distributed | IL, MA, MN, ND, OR, PA |
| Quantity | 211 units |
| Model numbers | 2124-1400 |
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 for recall
Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0964-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.