Stratum MDS Screw 3 — Class II medical device recall Z-0777-2020
Terminated recall by Nextremity Solutions, reported 2020-01-15, distributed nationwide. Components 2mm shorter than indicated on the package label
| Recall number | Z-0777-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nextremity Solutions, Warsaw, IN, United States |
| Recall initiated | 2019-11-11 |
| Classified | 2020-01-03 |
| Reported by FDA | 2020-01-15 |
| Terminated | 2020-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 86 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00817701023166 |
| Lot numbers | M1267 |
| Model numbers | STRM-MDS-3548ST |
Product
Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
Reason for recall
Components 2mm shorter than indicated on the package label
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-0777-2020. 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.