Home / Recalls / TriMed Inc. / Z-1214-2019

Z-1214-2019 Class II Terminated

Recalled by TriMed Inc. — Santa Clarita, CA

Recall Details

Product Type
Devices
Report Date
May 1, 2019
Initiation Date
August 24, 2018
Termination Date
December 28, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13 screws

Product Description

TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue healing. The TriMed Ankle Bone Plates and Screws are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process.

Reason for Recall

The bone screw is shorter than the intended design specification.

Distribution Pattern

US Distribution to states of FL and MO.

Code Information

Lot #170281, UDI (01)00842188107108(11)170406(10)170281

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)