3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
This recall has been terminated (originally issued August 24, 2015).
- Company
- Trilliant Surgical Ltd.
- Recall Initiated
- July 20, 2015
- Posted
- August 24, 2015
- Terminated
- January 26, 2017
- Recall Number
- Z-2452-2015
- Quantity
- 121 units
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
Reason for Recall
The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
Distribution
Nationwide Distribution including NY, TX, OH, IN, FL, NH, MN, SC, OK, NJ, CA, NC, MO, GA, WI, IA, TN, WA, and Puerto Rico.
Lot / Code Info
Lot 1363-01
Root Cause
Nonconforming Material/Component
Action Taken
Trilliant Surgical sent an Important Medical Device Advisory Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were instructed they have the option to exchange the affected drill bits at no charge. To initiate the exchange, customers were instructed to contact their local Trilliant Surgical Sales Representative or contact the Customer Service Department directly at 1-800-495-2919 or via email at orders@trilliantsurgical.com.