Z-0357-2020 Class II Ongoing
FDA device recall Z-0357-2020 was initiated by TriMed Inc. on September 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: 467 hex drivers.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- September 28, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 467 hex drivers
Product Description
TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, 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 numbers 91500604 and 91600017