Recall Z-0359-2020— TriMed Inc.
Class II · Ongoing
Class II FDA medical device recall by TriMed Inc., initiated 2018-09-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The WHD/WHV impactors can rust over time due to an improper manufacturing process..
- Recalling firm
- TriMed Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-09-28
- Firm location
- Santa Clarita, CA, United States
Product description
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.
Reason for recall
The WHD/WHV impactors can rust over time due to an improper manufacturing process.
Data sourced from openFDA. This site is unofficial and independent of the FDA.