Z-0609-2017Class II

Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm...

Name: Z-0609-2017 Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm...
Creator: Trilliant Surgical Ltd.
Published: 2016-09-02
License: https://open.fda.gov/license/

Trilliant Surgical LLC / initiated 2016-09-02 / Terminated / root cause: manufacturing process

FDA source

Trilliant Surgical Ltd. began a recall of Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29... on 2016-09-02. FDA classified it as Class II and gives the reason as "Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indicated lot number of...". 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-0609-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-02
Posted: 2016-11-17
Terminated: 2017-05-19
Recalling firm: Trilliant Surgical LLC
Product: Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD"
Product code: HWC Screw, Fixation, Bone
Reason for recall: Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indicated lot number of TSL003765 rather than TSL003721.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm sent out written notifcation of the recall on 9/2/16; the letter instructed the consignees to discontinue use of the affected lot, quarantine, and return product of the affected lot in accordance with an included acknowledgement sheet.
Quantity in commerce: 11
Distribution: CA, AZ, WI, FL, NJ, OH
Product codes and lots: Lot TSL003721

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0609-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0609-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-17

Product code HWC

K112737Class IITiger Headless Cannulated ScrewsTrilliant Surgical, Ltd. / cleared 2011-10-20

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)