TriMed Dorsal Wrist Hook Plate Recalled for Structural Integrity Issues
TriMed Inc. is recalling 5 Dorsal Wrist Hook Plates due to unqualified design modifications that may compromise structural integrity.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural vehicle defect equivalent in medical devices (structural integrity issues) which poses a significant risk of injury, aligning with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
TriMed Inc. is recalling 5 units of the TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole (REF WHD-4). The devices are nonsterile, single-use, and prescription-only. The affected lot numbers are 28884, 28885, 28886, and 28887.
The recall was initiated because modifications to the device specification were not appropriately qualified through the company's design control process. This failure in the design control process may result in structural integrity issues with the device.
Distribution of the affected devices was made to California, Florida, Maryland, Texas, and Washington, as well as to Australia. There was no government distribution. Healthcare providers and patients should contact TriMed Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- 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.
- Manufacturer
- TriMed Inc.
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot numbers 28884
- 28885
- 28886
- and 28887
Distribution
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