CLASS II Device recall · Reported 11 Jul 2018 · FDA Enforcement Report

Cannulated Driver Handle recalled by Trilliant Surgical

Trilliant Surgical is recalling Cannulated Driver Handle, distributed in 22 states. The recall was initiated on 27 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 603599

Quantity recalled94

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-2338-2018
FDA event ID: 80195
Recalling firm: Trilliant Surgical, Houston, TX
Classification: Class II
Status: Terminated
Recall initiated: 27 Mar 2018
FDA classified: 2 Jul 2018
Reported: 11 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

27 Mar 2018	Recall initiated by company
2 Jul 2018	Classified by FDA	+97 days
11 Jul 2018	Published in enforcement report	+9 days

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

Reason for recall

Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.

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

Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile

Where it was distributed

U.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO

Arizona California Delaware Florida Georgia Iowa Kansas Massachusetts Minnesota Missouri Montana Nebraska New Jersey Ohio Oklahoma Oregon Pennsylvania Texas Utah Virginia

Questions about this recall

Is Cannulated Driver Handle recalled?

Yes. Trilliant Surgical recalled Cannulated Driver Handle on 27 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-2338-2018.

Why was it recalled?

Which lots are affected?

Lot: 603599

Where was it sold?

U.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO

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.

More recalls from Trilliant Surgical

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8 Apr 2020Device	CLASS II	Instructions for Use and Surgical Cleaning recalled	Trilliant Surgical	Sterility	29 states
8 Apr 2020Device	CLASS II	Instructions for Use and Surgical Cleaning recalled	Trilliant Surgical	Sterility	29 states
8 Apr 2020Device	CLASS II	Instructions for Use and Surgical Cleaning recalled	Trilliant Surgical	Sterility	29 states
8 Apr 2020Device	CLASS II	Instructions for Use and Surgical Cleaning recalled	Trilliant Surgical	Sterility	29 states

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