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
This recall has been terminated (originally issued January 11, 2018).
- Company
- Trimed Inc.
- Recall Initiated
- January 11, 2018
- Terminated
- January 18, 2024
- Recall Number
- Z-1373-2018
- Quantity
- 1525 devices
- Firm Location
- Santa Clarita, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US, China, Latin America
Lot / Code Info
Affected lot numbers: 922361, 922362, 91956, 91957, 92237, 92238, 91858, 92235, 92656, 91856, 91857
Root Cause
Process control
Action Taken
Recall notification letters were sent to affected consignees on January 16, 2018. The consignee letter requests that the consignee return an initial Acknowledgement & Receipt Form to TriMed by January 23, 2018.
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