Z-0118-2020 Class II Terminated
FDA device recall Z-0118-2020 was initiated by TriMed Inc. on August 24, 2018 and is designated Class II. Reason for recall: Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device. The recall status is terminated (terminated April 28, 2021). Affected quantity: 5 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2019
- Initiation Date
- August 24, 2018
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 devices
Product Description
TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.
Reason for Recall
Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.
Distribution Pattern
Distribution was made to CA, FL, MD, TX, and WA. There was military and foreign distribution was made to Australia. There was no government distribution.
Code Information
Lot numbers 28884, 28885, 28886, and 28887