Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-0438-2013

April 25, 2011

Class II

Product summary

Firm
Extremity Medical LLC
Event
Event 62918
Status
Terminated
Classification
Class II
Quantity
156 units
Official record key
device-enforcement:Z-0438-2013

Official wording

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

Code information: Product coding is listed as Catalog Number: Lot Number and are as follows: 118-0005:126564; 118-30016:127375; 118-30018:AP6A08; 118-30020:AP6A07.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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