Z-0356-2020Class II

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

Name: Z-0356-2020 TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed...
Creator: TriMed Inc.
Published: 2018-09-28
License: https://open.fda.gov/license/

Trimed Inc / initiated 2018-09-28 / Open, Classified / root cause: manufacturing process

FDA source

TriMed Inc. began a recall of TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA on 2018-09-28. FDA classified it as Class II and gives the reason as "The epoxy on Apex manufactured epoxy-coated instruments can pop off". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0356-2020
Classification: Class II
Status: Open, Classified
Initiated: 2018-09-28
Posted: 2019-11-12
Recalling firm: Trimed Inc
Product: TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 1,042 drill guides
Distribution: Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
Product codes and lots: Lot numbers 3168, 3464, 3660, 3963, and 4216.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0356-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0355-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-20	2019-11-12
Z-0356-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-20	2019-11-12
Z-0357-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-20	2019-11-12
Z-0358-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-20	2019-11-12
Z-0359-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-20	2019-11-12

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)