FDAClass IINovember 20, 2019

TriMed Hex Driver 1.2 recall

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.

Why was TriMed Hex Driver 1.2 recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers 91500604 and 91600017

Product
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.
Recalling firm
TriMed Inc.
Quantity
467 hex drivers
Distribution
Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
Recall date
November 20, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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