Ergo 3 — Class II medical device recall Z-0168-2020
Terminated recall by Exactech, Inc., reported 2019-10-30, distributed nationwide. Potential for the wire to fracture at the threads and remain in the glenoid.
| Recall number | Z-0168-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2019-09-10 |
| Classified | 2019-10-21 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2023-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 158 devices |
| Reason classes | device malfunction |
| Model numbers | 321-52-06 |
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 for recall
Potential for the wire to fracture at the threads and remain in the glenoid.
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-0168-2020. 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.