Z-0438-2013Class II

IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post...

Name: Z-0438-2013 IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post...
Creator: Extremity Medical LLC
Published: 2011-04-25
License: https://open.fda.gov/license/

Extremity Medical, LLC / initiated 2011-04-25 / Terminated / root cause: manufacturing process

FDA source

Extremity Medical LLC began a recall of 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... on 2011-04-25. FDA classified it as Class II and gives the reason as "Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0438-2013
Classification: Class II
Status: Terminated
Initiated: 2011-04-25
Posted: 2012-11-26
Terminated: 2013-03-21
Recalling firm: Extremity Medical, LLC
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.
Product code: HTO Reamer
Reason for recall: Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 156 units
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0438-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0438-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-26

Product code HTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)