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Open, Classified

TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

FDA Recall Z-0357-2020 · Posted None

Recalling FirmTriMed Inc.
Recall StatusOpen, Classified
Product CodeLXH
Date Initiated2018-09-28
Product Quantity467 hex drivers

Reason for Recall

The epoxy on Apex manufactured epoxy-coated instruments can pop off.

Firm Action

The recalling firm issued letters via email on 9/28/2018 explaining the reason for recall and requesting consignees to identify potentially-affected product and quarantine it until a TriMed representative is able to conduct an inspection.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.

Official Source

View FDA Recall →

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

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