Stryker Vitallium Wire — Class II medical device recall Z-0855-2016
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2016-03-02, distributed nationwide. The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use
| Recall number | Z-0855-2016 |
|---|---|
| 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 | 2015-12-23 |
| Classified | 2016-02-23 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 3,741 units |
| Reason classes | labeling, sterility |
| Model numbers | 2704-1-024 |
Product
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Reason for recall
The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be resterilized. Since the IFU states the devices are sterile, no instructions for moist heat sterilization are provided.
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-0855-2016. 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.