FDA Device recall Z-1127-2020
Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467
- FDA Device
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467 by Nextremity Solutions, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1127-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-16 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nextremity Solutions |
| Distribution | AL, CA, FL, GA, IA, ID, IL, KY, LA, MA, ME, MI, MN, MS, NE, NJ, NY, OH, OK, OR, TX, WA |
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
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.
Identifiers
| code_info | Lot M1502 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1127-2020%22
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