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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

FDA Recall Z-1373-2018 · Posted None

Recalling FirmTriMed Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2018-01-11
Date Terminated2024-01-18
Product Quantity1525 devices

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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

US, China, Latin America

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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