Z-1892-2020Class II

3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 -

Name: Z-1892-2020 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 -
Creator: Trilliant Surgical, LLC
Published: 2019-10-10
License: https://open.fda.gov/license/

Trilliant Surgical LLC / initiated 2019-10-10 / Terminated / root cause: labeling and UDI

FDA source

Trilliant Surgical, LLC began a recall of 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant... on 2019-10-10. FDA classified it as Class II and gives the reason as "Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This could lead to parts being misidentified and impact device traceability". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1892-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-10
Posted: 2020-05-05
Terminated: 2022-04-27
Recalling firm: Trilliant Surgical LLC
Product: 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion
Product code: HTW Bit, Drill
Reason for recall: Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This could lead to parts being misidentified and impact device traceability.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 10/10/2019 the firm sent a "Urgent: Medical Device Recall" via: FedEx overnight to all consignees in receipt of the recalled product. In addition to informing consignees about the recall, they ask consignees to take the following actions: Check inventory stock for the identified device. 2. Locate and remove and/or discontinue use of identified device. 3. Return all products of the affected device to Trilliant Surgical in accordance with the included Return Response. 4. For questions regarding this communication, contact Trilliant Surgical at 800.495.2919. (Monday Friday, 8:00AM 5:00 CST)
Quantity in commerce: 5 drill bits
Distribution: US Nationwide distribution in the state of CA. OUS: None
Product codes and lots: Lot # TSL008495A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1892-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1892-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-05

Product code HTW

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)