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U.S. Department of Health and Human Services

Class 2 Device Recall 3.5mm Aresenal screw Drill Bit

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  Class 2 Device Recall 3.5mm Aresenal screw Drill Bit see related information
Date Initiated by Firm October 10, 2019
Create Date May 05, 2020
Recall Status1 Terminated 3 on April 27, 2022
Recall Number Z-1892-2020
Recall Event ID 85374
Product Classification Bit, drill - Product Code HTW
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
Code Information Lot # TSL008495A
Recalling Firm/
Manufacturer		 Trilliant Surgical, LLC
727 N Shepherd Dr Ste 100
Houston TX 77007-1320
For Additional Information Contact Trilliant Surgical
800-495-2919
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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