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Terminated

DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY, NON-STERILE, EC REP Wright Medical EMEA, Krijgsman 11, 1186 DM Amstelveen, The Netherlands, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002

FDA Recall Z-2470-2010 · Posted 2010-09-22

Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeHXX
Date Initiated2010-08-26
Date Terminated2012-08-02
Product Quantity13 units

Reason for Recall

After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake.

Firm Action

The firm initiated their recall the product by letter on 08/26/2010. The letters were addressed to distributors and hospital administrators with a fax back response form. Please contact Customer Service at 800-238-7117, if you have any questions.

Root Cause

Process design

Distribution Pattern

TX, PA, TN, VA, GA, and Spain

Official Source

View FDA Recall →

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

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