Recall Z-1373-2018— TriMed Inc.
Class II · Terminated
Class II FDA medical device recall by TriMed Inc., initiated 2018-01-11, terminated 2024-01-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- TriMed Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-11
- Terminated
- 2024-01-18
- Firm location
- Santa Clarita, CA, United States
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.