Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE;

FDA device recall Z-2464-2015 · posted 2015-08-26 · Terminated

Recall details

Recalling firm

Trilliant Surgical Ltd.

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.

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.

Root cause

Component design/selection

Status

Terminated

Product code

HWC

Quantity affected

71 units

Distribution

Nationwide Distribution

Date initiated

2015-07-20

Date posted

2015-08-26

Date terminated

2017-01-26

Location

Houston, TX

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