Class 2 Device Recall Cannulated Driver Handles

• Date Initiated by Firm: March 27, 2018
• Create Date: July 02, 2018
• Recall Status: Terminated on June 04, 2020
• Recall Number: Z-2338-2018
• Recall Event ID: 80195
• Product Classification: Instrument, manual, surgical, general use - Product Code MDM
• Product: Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile
• Code Information: Lot: 603599
• FEI Number: 3007420745
• Recalling Firm/ Manufacturer: Trilliant Surgical Ltd.; 727 N Shepherd Dr Ste 100; Houston TX 77007-1320
• For Additional Information Contact: Jon Olson; 713-388-6055
• Manufacturer Reason for Recall: Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.
• FDA Determined Cause: Other
• Action: On 03/27/18, the firm sent Medical Device Recall notices to customers informing them to: 1) Check inventory stock for identified devices; 2) Locate and remove and/or discontinue use of identified devices; 3) Return all related product(s) to the firm in accordance with an included return response / acknowledgement form. Customers were instructed to contact the firm at 1-800-495-2919 to organize product returns.
• Quantity in Commerce: 94
• Distribution: U.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO
• 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.