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Terminated

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

FDA Recall Z-2679-2014 · Posted 2014-09-22

Recalling FirmInstratek, Incorporated
Recall StatusTerminated
Product CodeHWC
Date Initiated2013-04-25
Date Terminated2016-01-26
Product Quantity96

Reason for Recall

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120493MINI CANNULATED HEADED AND HEADLESS SCREW SETInstratek, Inc. · 2012-05-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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