Z-2456-2015Class II

Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22...

Name: Z-2456-2015 Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22...
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 Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head... on 2015-07-20. FDA classified it as Class II and gives the reason as "The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through". 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-2456-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-20
Posted: 2015-08-24
Terminated: 2017-01-26
Recalling firm: Trilliant Surgical LLC
Product: Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones.
Product code: HTO Reamer
Reason for recall: The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.
Root cause tag: design
FDA root cause: Component design/selection
Action: The recalling firm sent out written notification of the recall on 7/3/14. The letter instructed the consignees to exchange affected instruments.
Quantity in commerce: 638 units
Distribution: Nationwide throughout the US
Product codes and lots: TSL000145, TSL000162, TSL000699, TSL000146, TSL000163, TSL000700, TSL00147, TSL000164, TSL000701, TSL000702, TSL000148, TSL000165, TSL000706, TSL000149, TSL000166, TSL000688, TSL000150, TSL000167, TSL000707, TSL000708

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2456-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2456-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-24

Product code HTO

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

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)