FDA Medical Device Recalls (openFDA)
Trilliant Surgical, LLC: 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
- Recall number
- Z-1892-2020
- 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
- Status
- Terminated
- Initiated
- 2019-10-10
- Posted
- not on file
- Terminated
- 2022-04-27
- Reason
- 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
- 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
- 5 drill bits
- Distribution
- US Nationwide distribution in the state of CA. OUS: None
- Lot, serial or model codes
- Lot # TSL008495A
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTW
- Firm FEI
- 3007420745
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28