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.
Reported: October 16, 2019 Initiated: August 24, 2018 #Z-0118-2020
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.
Details
- Recalling Firm
- TriMed Inc.
- Units Affected
- 5 devices
- Distribution
- 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.
- Location
- Santa Clarita, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by TriMed Inc.. Units affected: 5 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2019. Severity: Moderate. Recall number: Z-0118-2020.
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