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.
FDA Recall Z-2464-2015 · Posted 2015-08-26
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Recalling FirmTrilliant Surgical Ltd.
Recall StatusTerminated
Product CodeHWC
Date Initiated2015-07-20
Date Terminated2017-01-26
Product Quantity71 units
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.
Firm Action
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 [email protected].
Root Cause
Component design/selection
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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