FDA Device recall Z-0855-2016
Stryker Vitallium Wire (6 Pack) Non Sterile
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of Stryker Vitallium Wire (6 Pack) Non Sterile by Stryker Howmedica Osteonics, citing 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 shou….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0855-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-23 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
Product
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Reason
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.
Identifiers
| code_info | All lots of the following Catalog Numbers: 2704-1-024; 2704-3-018; 6703-1-018; 6703-2-120; 6704-1-018; 6704-2-120 and 6704-3-120. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2016-10-19 · Stryker Howmedica Osteonics
All Stryker Howmedica Osteonics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0855-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.