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Terminated

IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.

FDA Recall Z-0438-2013 · Posted 2012-11-26

Recalling FirmExtremity Medical LLC
Recall StatusTerminated
Product CodeHTO
Date Initiated2011-04-25
Date Terminated2013-03-21
Product Quantity156 units

Reason for Recall

Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.

Firm Action

Extremity Medical sent a notification by e-mail that describes the "Slight modification to the Surgical Technique" on April 25, 2011. For questions regarading this recall call 973-588-8980.

Root Cause

Employee error

Distribution Pattern

Worldwide Distribution - USA including FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE. Internationally to Switzerland.

Official Source

View FDA Recall →

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

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