Z-2679-2014Class II

Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in...

Name: Z-2679-2014 Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in...
Creator: Instratek, Incorporated
Published: 2013-04-25
License: https://open.fda.gov/license/

Instratek, Incorporated / initiated 2013-04-25 / Terminated / root cause: manufacturing process

FDA source

Instratek, Incorporated began a recall of Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System on 2013-04-25. FDA classified it as Class II and gives the reason as "Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set". 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-2679-2014
Classification: Class II
Status: Terminated
Initiated: 2013-04-25
Posted: 2014-09-22
Terminated: 2016-01-26
Recalling firm: Instratek, Incorporated
Product: Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
Product code: HWC Screw, Fixation, Bone
Reason for recall: Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm plans to notify their customers of the recall via email, telephone and visit. The firm then plans to scrap and discard any affected product.
Quantity in commerce: 96
Distribution: Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado
Product codes and lots: Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2679-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2679-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-22

Product code HWC

K120493Class IIMini Cannulated Headed and Headless Screw SetInstratek, Inc. / cleared 2012-05-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)