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
This recall has been terminated (originally issued October 10, 2019).
- Company
- Trilliant Surgical, Llc
- Recall Initiated
- October 10, 2019
- Terminated
- April 27, 2022
- Recall Number
- Z-1892-2020
- Quantity
- 5 drill bits
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the state of CA. OUS: None
Lot / Code Info
Lot # TSL008495A
Root Cause
Labeling design
Action Taken
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)