Stratum Lapidus Plate — Class II medical device recall Z-1127-2020
Terminated recall by Nextremity Solutions, reported 2020-02-19, distributed in AL, CA, FL, GA, IA, ID, IL, KY…. The product contains a different plate than indicated by the package labeling. The product is labeled as a rig
| Recall number | Z-1127-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nextremity Solutions, Warsaw, IN, United States |
| Recall initiated | 2019-12-16 |
| Classified | 2020-02-10 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2020-09-08 |
| Distributed | AL, CA, FL, GA, IA, ID, IL, KY, LA, MA, ME, MI, MN, MS, NE, NJ, NY, OH, OK, OR, TX, WA |
| Quantity | 40 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00817701025467 |
| Lot numbers | M1502 |
Product
Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
Reason for recall
The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
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-1127-2020. 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.