Z-0438-2013 Class II Terminated
FDA device recall Z-0438-2013 was initiated by Extremity Medical LLC on April 25, 2011 and is designated Class II. Reason for recall: Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming. The recall status is terminated (terminated March 21, 2013). Affected quantity: 156 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 5, 2012
- Initiation Date
- April 25, 2011
- Termination Date
- March 21, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 156 units
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.
Reason for Recall
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
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.
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.