TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
This recall is currently active, issued September 28, 2018. It was issued by Trimed Inc..
- Company
- Trimed Inc.
- Recall Initiated
- September 28, 2018
- Recall Number
- Z-0355-2020
- Quantity
- 99 instruments
- Firm Location
- Santa Clarita, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Distribution
Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
Lot / Code Info
Lot number 91401455
Root Cause
Nonconforming Material/Component
Action Taken
The recalling firm issued letters via email on 9/28/2018 explaining the reason for recall and requesting consignees to identify potentially-affected product and quarantine it until a TriMed representative is able to conduct an inspection.
More recalls by Trimed Inc.
TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only
TriMed, Threade...
May 10, 2024
TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only
TriMed, Threade...
May 10, 2024
Volar Bearing Plate.
REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W,...
Jan 31, 2024
RipCord Syndesmosis Button, REF: STA001K
Feb 7, 2023