TriMed Wrist Hook Impactors Recalled for Rust Risk
TriMed Inc. is recalling 561 Wrist Hook Dorsal and Volar Impactors because they can rust due to an improper manufacturing process.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is rust formation due to manufacturing defects, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text, placing it in the High severity category per the rubric.
Plain-English summary
TriMed Inc. is recalling 561 units of the TriMed Wrist Hook Dorsal Impactor (REF IMPCT-WHD) and TriMed Wrist Hook Volar Impactor (REF IMPCT-WHV). These are nonsterile, prescription medical devices manufactured in Santa Clarita, California. The recall covers lot numbers 049045, 049044, and 049044R1.
The devices are being recalled because they can rust over time due to an improper manufacturing process. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
Distribution was nationwide, including military distribution, and foreign distribution to Australia, China, South Africa, and Sweden. Healthcare providers and patients should stop using these devices and contact TriMed Inc. for instructions on return or replacement.
The recalled product
- Product
- TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.
- Manufacturer
- TriMed Inc.
- Hazard
- Affected units
- 561
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 (3)
- Lot numbers 049045
- 049044
- and 049044R1.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by TriMed Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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