FDA Device recall Z-0878-2016
Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments by Stryker Howmedica Osteonics, citing during a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0878-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-21 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
Product
Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Reason
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Identifiers
| code_info | Catalog number 1806-0085S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0878-2016%22
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