FDA Device recall Z-0438-2013
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com
- FDA Device
- Class II
- terminated
- Published 2012-12-05
On 2012-12-05 the FDA classified a Class II recall of IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com by Extremity Medical, citing product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0438-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-04-25 |
| Published | 2012-12-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Extremity Medical |
| Distribution | AL, AZ, CA, FL, GA, IA, IL, IN, MA, MD, MI, MT, NC, NE, NJ, NY, OH, OK, TN, TX, VA, WI |
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.
Reason
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
Identifiers
| code_info | 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0438-2013%22
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