Extremity Medical LLC: Medical Device Recall in 2012 - (Recall #: Z-0438-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 25, 2011

Date Posted: December 5, 2012

Recall Number: Z-0438-2013

Event ID: 62918

Reason for Recall:

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

Status: Terminated

Product Quantity: 156 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated