FDA Device recall Z-0168-2020
Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components accord…
- FDA Device
- Class II
- terminated
- Published 2019-10-30
On 2019-10-30 the FDA classified a Class II recall of Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components accord… by Exactech, citing potential for the wire to fracture at the threads and remain in the glenoid.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0168-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-10 |
| Published | 2019-10-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Exactech |
| Distribution | US |
Product
Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
Reason
Potential for the wire to fracture at the threads and remain in the glenoid.
Identifiers
| code_info | Catalog Number: 321-52-06, All Serial Numbers |
|---|
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-0168-2020%22
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