Stratum Foot Plating System-NL LP Screw 3 — Class II medical device recall Z-0534-2020
Terminated recall by Nextremity Solutions, reported 2019-12-04, distributed nationwide. Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and
| Recall number | Z-0534-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nextremity Solutions, Warsaw, IN, United States |
| Recall initiated | 2019-10-09 |
| Classified | 2019-11-22 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2020-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 49 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00817701022558 |
| Lot numbers | M1151 |
| Model numbers | STRM-NL-3550ST |
Product
Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.
Reason for recall
Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
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-0534-2020. 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.