Home / Recalls / TriMed Inc. / Z-0366-2020

Z-0366-2020 Class II Terminated

Recalled by TriMed Inc. — Santa Clarita, CA

Recall Details

Product Type
Devices
Report Date
November 20, 2019
Initiation Date
August 15, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
583 Bone Plates

Product Description

TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization.

Reason for Recall

The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.

Distribution Pattern

US Nationwide distribution in the states of MD, UT.

Code Information

Lot # 110631,

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-0118-2020 Class II — TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, (August 24, 2018)