Z-2490-2015Class II

7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula...

Name: Z-2490-2015 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula...
Creator: Trilliant Surgical Ltd.
Published: 2015-08-06
License: https://open.fda.gov/license/

Trilliant Surgical LLC / initiated 2015-08-06 / Terminated / root cause: manufacturing process

FDA source

Trilliant Surgical Ltd. began a recall of 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY... on 2015-08-06. FDA classified it as Class II and gives the reason as "The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficient, potentially...". 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-2490-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-06
Posted: 2015-08-31
Terminated: 2017-01-26
Recalling firm: Trilliant Surgical LLC
Product: 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficient, potentially limiting the ability to engage and lock with associated mating locking screws.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Trilliant Surgical sent an Urgent Medical Device Recall letter dated August 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed and confirmed consignees to discontinue use of the affected lots, quarantine, and return product (if not yet done so) in accordance with an included acknowledgement sheet. For further questions, please call 1(800) 495-2919 , 8:00am - 5:00pm CST
Quantity in commerce: 28 units
Distribution: US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA.
Product codes and lots: Lots: TSL002595, TSL002596, TSL002597

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2490-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2490-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31

Product code HRS

K121452Class IIGridlock Plating SystemTrilliant Surgical, Ltd. / cleared 2012-08-20

Process control is the most common named cause of a device recall11 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)