Device product
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.
Z-2464-2015
Product summary
- Event
- Event 71813
- Status
- Terminated
- Classification
- Class II
- Quantity
- 71 units
- Official record key
device-enforcement:Z-2464-2015
Official wording
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 information: Lot Numbers ALU120514552473 and 45479
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.