Recall Z-1892-2020 ยท HTW Bit, Drill
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
| Date | Oct 10, 2019 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.