Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile
This recall has been terminated (originally issued March 27, 2018).
- Company
- Trilliant Surgical Ltd.
- Recall Initiated
- March 27, 2018
- Terminated
- June 4, 2020
- Recall Number
- Z-2339-2018
- Quantity
- 90
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
Lot: 603600
Root Cause
Other
Action Taken
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.