2 — Class II medical device recall Z-0361-2020
Terminated recall by Exactech, Inc., reported 2019-11-20, distributed nationwide. Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
| Recall number | Z-0361-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2019-10-02 |
| Classified | 2019-11-12 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2023-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 9 units |
| UPC / GTIN / UDI-DI | 10885862567529 |
| Lot numbers | 19030412 |
| Serial numbers | 6189221, 6189222, 6189223, 6189228, 6189229, 6189249, 6189262 |
| Model numbers | 351-90-22 |
| Expiration dates | 2028-08-28 |
Product
2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use.
Reason for recall
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
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-0361-2020. 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.