Recall Z-2679-2014— Instratek, Incorporated

Name: FDA recall Z-2679-2014
Creator: U.S. Food and Drug Administration
Published: 2013-04-25

Class II · Terminated

Class II FDA medical device recall by Instratek, Incorporated, initiated 2013-04-25, terminated 2016-01-26. It names one FDA 510(k) clearance: K120493. 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. Reason: Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set..

Recalling firm: Instratek, Incorporated
Classification: Class II
Status: Terminated
Initiated: 2013-04-25
Terminated: 2016-01-26
Firm location: Houston, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K120493 — MINI CANNULATED HEADED AND HEADLESS SCREW SETInstratek, Inc.·cleared 2012-05-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.

Data sourced from openFDA. This site is unofficial and independent of the FDA.