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Recall Observatory FDA recall evidence

Device 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

Z-1373-2018

January 11, 2018

Class II

Product summary

Firm
TriMed Inc.
Event
Event 79224
Status
Terminated
Classification
Class II
Quantity
1525 devices
Official record key
device-enforcement:Z-1373-2018

Official wording

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.

Code information: Affected lot numbers: 922361, 922362, 91956, 91957, 92237, 92238, 91858, 92235, 92656, 91856, 91857

Distribution pattern: US, China, Latin America

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.