Recall Z-2464-2015— Trilliant Surgical Ltd.

Name: FDA recall Z-2464-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-20

Class II · Terminated

Class II FDA medical device recall by Trilliant Surgical Ltd., initiated 2015-07-20, terminated 2017-01-26. It names 2 FDA 510(k) clearances: K112737, K081510. 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.. 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..

Recalling firm: Trilliant Surgical Ltd.
Classification: Class II
Status: Terminated
Initiated: 2015-07-20
Terminated: 2017-01-26
Firm location: Houston, TX, United States

510(k) clearances named in this recall

2 on FDA's record

K112737 — TIGER HEADLESS CANNULATED SCREWSTrilliant Surgical, Ltd.·cleared 2011-10-20
K081510 — TIGER CANNULATED SCREW SYSTEMTrilliant Surgical, Ltd.·cleared 2008-08-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.