VariAx Compression Plating System — Class II medical device recall Z-1507-2016
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2016-04-27, distributed nationwide. Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw we
| Recall number | Z-1507-2016 |
|---|---|
| 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 | 2013-10-10 |
| Classified | 2016-04-18 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2016-04-21 |
| Distributed | Nationwide (US) |
| Quantity | 118 units |
| Model numbers | 629503S, 629504S, 629505S, 629506S, 629507S, 629508S, 629509S, 629510S, 629527S, 629537S, 629543S, 629544S, 629545S, 629546S, 629547S, 629548S, 629559S, 629560S, 629561S, 629562S, 629564S, 629566S, 629568S, 629570S |
Product
VariAx Compression Plating System
Reason for recall
Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.
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-1507-2016. 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.