FDA Device recall Z-0361-2020
2.4mm x 2.5 Fluted Pin Pouch
- FDA Device
- Class II
- terminated
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of 2.4mm x 2.5 Fluted Pin Pouch by Exactech, citing potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0361-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-02 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Exactech |
| Distribution | US |
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
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
Identifiers
| code_info | Catalog Number: 351-90-22; UDI Number: 10885862567529; Expiration Date: 08/28/2028; Serial Numbers (6189213, 6189221,…Catalog Number: 351-90-22; UDI Number: 10885862567529; Expiration Date: 08/28/2028; Serial Numbers (6189213, 6189221, 6189222, 6189223, 6189228, 6189229, 6189249, 6189262, 6189273); Packaging Lots Numbers (49079322, 49079321); Manufacturing Lot Number:19030412 |
|---|
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-0361-2020%22
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