Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tiger Headless 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 26, 2015).
- Company
- Trilliant Surgical Ltd.
- Recall Initiated
- July 20, 2015
- Posted
- August 26, 2015
- Terminated
- January 26, 2017
- Recall Number
- Z-2464-2015
- Quantity
- 71 units
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.
Distribution
Nationwide Distribution
Lot / Code Info
Lot Numbers ALU120514552473 and 45479
Root Cause
Component design/selection
Action Taken
Trilliant sent an Important Medical Device Adivsory Notice dated November 6, 2013, to all affected customers. The letter instructed customers that they have the option of exchanging affected instruments for trays that meet specification at no charge. To initiate the exchange, customers were instructed to contact their local Trilliant Surgical sales representative or the Customer Service Department directly at 1-800-495-2919, or via email at orders@trilliantsurgical.com.