FDA Device recall Z-1458-2020
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile
- FDA Device
- Class II
- terminated
- Published 2020-03-18
On 2020-03-18 the FDA classified a Class II recall of Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile by Nextremity Solutions, citing proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1458-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-12 |
| Published | 2020-03-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nextremity Solutions |
| Distribution | n/a |
Product
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Reason
Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
Identifiers
| code_info | Lot Number: 168117318B UDI: 00817701020011 |
|---|
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-1458-2020%22
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