Home / Recalls / TriMed Inc. / Z-1373-2018

Z-1373-2018 Class II Terminated

Recalled by TriMed Inc. — Santa Clarita, CA

Recall Details

Product Type
Devices
Report Date
April 18, 2018
Initiation Date
January 11, 2018
Termination Date
January 18, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1525 devices

Product Description

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 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.

Distribution Pattern

US, China, Latin America

Code Information

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

Other recalls by TriMed Inc.

  • Z-1791-2024 Class II — TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx (March 19, 2024)
  • Z-1792-2024 Class II — TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx (March 19, 2024)
  • Z-0932-2024 Class II — Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VB (November 28, 2023)
  • Z-1101-2023 Class II — RipCord Syndesmosis Button, REF: STA001K (December 22, 2022)
  • Z-0359-2020 Class II — TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Im (September 28, 2018)
  • Z-0356-2020 Class II — TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm (September 28, 2018)
  • Z-0358-2020 Class II — TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the (September 28, 2018)
  • Z-0357-2020 Class II — TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. (September 28, 2018)
  • Z-0355-2020 Class II — TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on (September 28, 2018)
  • Z-1214-2019 Class II — TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a componen (August 24, 2018)