FDA Enforcement
Class II
Terminated
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.
Recall: Z-2464-2015
·
Reported September 2, 2015
Enforcement
- Recall Number
- Z-2464-2015
- Event ID
- 71813
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Trilliant Surgical Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 2, 2015
- Initiation Date
- July 20, 2015
- Classification Date
- August 26, 2015
- Termination Date
- January 26, 2017
- Address
- 6721 Portwest Dr Ste 160, N/A, Houston, TX, 77024-8019, United States
Description
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.
Reason
Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.
Code Info
Lot Numbers ALU120514552473 and 45479
Distribution
Nationwide Distribution
Quantity
71 units