Z-0960-2017Class II

Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a...

Name: Z-0960-2017 Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a...
Creator: Trilliant Surgical Ltd.
Published: 2016-12-08
License: https://open.fda.gov/license/

Trilliant Surgical LLC / initiated 2016-12-08 / Terminated / root cause: packaging

FDA source

Trilliant Surgical Ltd. began a recall of Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures... on 2016-12-08. FDA classified it as Class II and gives the reason as "Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035"...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0960-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-08
Posted: 2017-01-06
Terminated: 2017-05-17
Recalling firm: Trilliant Surgical LLC
Product: Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Trilliant Surgical Ltd. sent an Urgent Medical Device Recall letter dated December 8, 2016, to all affected consignees. The letter instructed the consignees to 1) identify any/all affected product; 2) document any/all identified product via a provided response form and return to Trilliant Surgical; 3) exchange product upon receipt of replacements; and 4) return any/all affected product as originally identified and reported on the return response form. Customers with questions were instructed to call 800-495-2919.
Quantity in commerce: 50 units
Distribution: Nationwide Distribution
Product codes and lots: Lot: TSL003191, TSL003637, TSL004101, TSL004395

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0960-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0960-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-06

Product code HWC

K153338Class IITiger Cannulated Screw SystemTrilliant Surgical, Ltd. / cleared 2016-01-14

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)