FDA Device recall Z-0534-2020
Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile by Nextremity Solutions, citing product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0534-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-09 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nextremity Solutions |
| Distribution | US |
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
Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
Identifiers
| code_info | Lot Number: M1151 UDI: 00817701022558 |
|---|
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-0534-2020%22
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