Home / Recalls / TriMed Inc. / Z-0355-2020

Z-0355-2020 Class II Ongoing

Recalled by TriMed Inc. — Santa Clarita, CA

Recall Details

Product Type
Devices
Report Date
November 20, 2019
Initiation Date
September 28, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
99 instruments

Product Description

TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Reason for Recall

The epoxy on Apex manufactured epoxy-coated instruments can pop off.

Distribution Pattern

Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.

Code Information

Lot number 91401455

Other recalls by TriMed Inc.

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  • 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-0118-2020 Class II — TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, (August 24, 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)