Z-0359-2020 Class II Ongoing
FDA device recall Z-0359-2020 was initiated by TriMed Inc. on September 28, 2018 and is designated Class II. Reason for recall: The WHD/WHV impactors can rust over time due to an improper manufacturing process. The recall status is ongoing. Affected quantity: 561 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- September 28, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 561 devices
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.
Distribution Pattern
Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
Code Information
Lot numbers 049045, 049044, and 049044R1.