Z-2421-2015Class II

2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink...

Name: Z-2421-2015 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink...
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 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The... on 2015-07-20. FDA classified it as Class II and gives the reason as "The cutting efficiency of the Countersinks was out of specification". 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-2421-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-20
Posted: 2015-08-19
Terminated: 2017-01-26
Recalling firm: Trilliant Surgical LLC
Product: 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: 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: HWC Screw, Fixation, Bone
Reason for recall: The cutting efficiency of the Countersinks was out of specification.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Trilliant sent an Important Medical Device Advisory Notice letter dated February 15, 2013 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers of the option to exchange affected instruments at no charge. To initiate the exchange customers were instructed to contact your local Trilliant Surgical Sales Representative, contact the Customer Service Department directly at 1-800-495-2919, or via email at [email protected].
Quantity in commerce: 102 units
Distribution: US Nationwide Distribution in the states of: NY, CT, TN, TX, OH, IN, LA, NC, MO, MN, GA, FL, SC, WA, WI, IA, PA, CA, ND, OK, NJ, MI and MD.
Product codes and lots: Lot numbers 1362-01 and 1364-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2421-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2421-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19

Product code HWC

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

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)