Z-0355-2020 Class II Ongoing
FDA device recall Z-0355-2020 was initiated by TriMed Inc. on Sep 28, 2018 and is designated Class II. Reason for recall: The epoxy on Apex manufactured epoxy-coated instruments can pop off. The recall status is ongoing. Affected quantity: 99 instruments.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 20, 2019
- Initiation Date
- Sep 28, 2018
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0355-2020
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026