Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4)… — Class I medical device recall Z-1976-2013
Terminated recall by Stryker Spine, reported 2013-08-28, distributed nationwide. Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tu
| Recall number | Z-1976-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Spine, Allendale, NJ, United States |
| Recall initiated | 2013-05-30 |
| Classified | 2013-08-22 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2014-12-30 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
Product
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
Reason for recall
Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
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-1976-2013. 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.