Z-2452-2015Class II

3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw...

Name: Z-2452-2015 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw...
Creator: Trilliant Surgical Ltd.
Published: 2015-07-20
License: https://open.fda.gov/license/

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

FDA source

Trilliant Surgical Ltd. began a recall of 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of... on 2015-07-20. FDA classified it as Class II and gives the reason as "The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2452-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-20
Posted: 2015-08-24
Terminated: 2017-01-26
Recalling firm: Trilliant Surgical LLC
Product: 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger 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: HTW Bit, Drill
Reason for recall: The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Trilliant Surgical sent an Important Medical Device Advisory Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were instructed they have the option to exchange the affected drill bits at no charge. To initiate the exchange, customers were instructed to contact their local Trilliant Surgical Sales Representative or contact the Customer Service Department directly at 1-800-495-2919 or via email at [email protected].
Quantity in commerce: 121 units
Distribution: Nationwide Distribution including NY, TX, OH, IN, FL, NH, MN, SC, OK, NJ, CA, NC, MO, GA, WI, IA, TN, WA, and Puerto Rico.
Product codes and lots: Lot 1363-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2452-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2452-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-24

Product code HTW

K081510Class IITiger Cannulated Screw SystemTrilliant Surgical, Ltd. / cleared 2008-08-04

MDM coverage of this record lists here, newest first.

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)