FDA Device recall Z-1373-2018
Hex Driver Part Number HXDRIVER-2.0 AO
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of Hex Driver Part Number HXDRIVER-2.0 AO by Trimed, citing following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1373-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-11 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Trimed |
| Distribution | n/a |
Product
Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO
Reason
Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.
Identifiers
| code_info | Affected lot numbers: 922361, 922362, 91956, 91957, 92237, 92238, 91858, 92235, 92656, 91856, 91857 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1373-2018%22
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