FDA Enforcement
Class II
Terminated
Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO
Recall: Z-1373-2018
·
Reported April 18, 2018
Enforcement
- Recall Number
- Z-1373-2018
- Event ID
- 79224
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- TriMed Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 18, 2018
- Initiation Date
- January 11, 2018
- Classification Date
- April 12, 2018
- Termination Date
- January 18, 2024
- Address
- 27533 Avenue Hopkins, Santa Clarita, CA, 91355-3910, United States
Description
Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO
Reason
Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.
Code Info
Affected lot numbers: 922361, 922362, 91956, 91957, 92237, 92238, 91858, 92235, 92656, 91856, 91857
Distribution
US, China, Latin America
Quantity
1525 devices