Z-1373-2018Class II

Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number...

Name: Z-1373-2018 Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number...
Creator: TriMed Inc.
Published: 2018-01-11
License: https://open.fda.gov/license/

Trimed Inc / initiated 2018-01-11 / Terminated / root cause: manufacturing process

FDA source

TriMed Inc. began a recall of 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... on 2018-01-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1373-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-11
Posted: 2018-04-12
Terminated: 2024-01-18
Recalling firm: Trimed Inc
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
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall notification letters were sent to affected consignees on January 16, 2018. The consignee letter requests that the consignee return an initial Acknowledgement & Receipt Form to TriMed by January 23, 2018.
Quantity in commerce: 1525 devices
Distribution: US, China, Latin America
Product codes and lots: Affected lot numbers: 922361, 922362, 91956, 91957, 92237, 92238, 91858, 92235, 92656, 91856, 91857

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1373-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1373-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-12

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)