Home / Recalls / TriMed Inc. / Z-1101-2023

Z-1101-2023 Class II Ongoing

Recalled by TriMed Inc. — Santa Clarita, CA

Recall Details

Product Type
Devices
Report Date
February 15, 2023
Initiation Date
December 22, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
76

Product Description

RipCord Syndesmosis Button, REF: STA001K

Reason for Recall

Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.

Distribution Pattern

US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS

Code Information

UDI-DI: 00842188123849, Lot: 85305-01

Other recalls by TriMed Inc.

  • 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-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-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-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)
  • 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)