Stryker — Class II medical device recall Z-0875-2016
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2016-03-02, distributed nationwide. During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
| Recall number | Z-0875-2016 |
|---|---|
| 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 | 2016-01-21 |
| Classified | 2016-02-24 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 147,838 units |
| Reason classes | packaging |
| Model numbers | 1806-0080S |
Product
Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Reason for recall
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0875-2016. 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.