Z-2464-2015Class II

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

Name: Z-2464-2015 Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101...
Creator: Trilliant Surgical Ltd.
Published: 2015-07-20
License: https://open.fda.gov/license/

Trilliant Surgical LLC / initiated 2015-07-20 / Terminated / root cause: design

FDA source

Trilliant Surgical Ltd. began a recall of 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... on 2015-07-20. FDA classified it as Class II and gives the reason as "Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2464-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-20
Posted: 2015-08-26
Terminated: 2017-01-26
Recalling firm: Trilliant Surgical LLC
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.
Product code: HWC Screw, Fixation, Bone
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.
Root cause tag: design
FDA root cause: Component design/selection
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].
Quantity in commerce: 71 units
Distribution: Nationwide Distribution
Product codes and lots: Lot Numbers ALU120514552473 and 45479

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2464-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2464-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-26

Product code HWC

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)