CLASS II ONGOING Device recall · Reported 20 Nov 2019 · FDA Enforcement Report

Locking Drill Guide recalled by TriMed

TriMed is recalling TriMed Locking Drill Guide, distributed nationwide in the US. The recall was initiated on 28 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers 3168, 3464, 3660, 3963, and 4216.
Quantity recalled1,042 drill guides

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0356-2020
FDA event ID
83820
Recalling firm
TriMed, Santa Clarita, CA
Classification
Class II
Status
Ongoing
Recall initiated
28 Sep 2018
FDA classified
12 Nov 2019
Reported
20 Nov 2019
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

28 Sep 2018Recall initiated by company
12 Nov 2019Classified by FDA+410 days
20 Nov 2019Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Where it was distributed

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

Nationwide

Questions about this recall

Is Locking Drill Guide recalled?

Yes. TriMed recalled Locking Drill Guide on 28 Sep 2018. The recall is Class II and its status is Ongoing. Recall number Z-0356-2020.

Why was it recalled?

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

Which lots are affected?

Lot numbers 3168, 3464, 3660, 3963, and 4216.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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