Z-2338-2018Class II

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

Name: Z-2338-2018 Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile
Creator: Trilliant Surgical Ltd.
Published: 2018-03-27
License: https://open.fda.gov/license/

Trilliant Surgical LLC / initiated 2018-03-27 / Terminated

FDA source

Trilliant Surgical Ltd. began a recall of Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile on 2018-03-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2338-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-27
Posted: 2018-07-02
Terminated: 2020-06-04
Recalling firm: Trilliant Surgical LLC
Product: Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile
Product code: MDM Instrument, Manual, Surgical, General Use
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.
FDA root cause: Other
Action: On 03/27/18, the firm sent Medical Device Recall notices to customers informing them to: 1) Check inventory stock for identified devices; 2) Locate and remove and/or discontinue use of identified devices; 3) Return all related product(s) to the firm in accordance with an included return response / acknowledgement form. Customers were instructed to contact the firm at 1-800-495-2919 to organize product returns.
Quantity in commerce: 94
Distribution: 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
Product codes and lots: Lot: 603599

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2338-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2338-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-02
Z-2339-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-02

Product code MDM

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)