CLASS II Device recall · Reported 5 Dec 2012 · FDA Enforcement Report

IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com recalled

Extremity Medical is recalling IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com, distributed nationwide in the US. The recall was initiated on 25 Apr 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct coding is listed as Catalog Number: Lot Number and are as follows: 118-0005:126564; 118-30016:127375; 118-30018:AP6A08; 118-30020:AP6A07.

Quantity recalled156 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0438-2013
FDA event ID: 62918
Recalling firm: Extremity Medical, Parsippany, NJ
Classification: Class II
Status: Terminated
Recall initiated: 25 Apr 2011
FDA classified: 26 Nov 2012
Reported: 5 Dec 2012
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

25 Apr 2011	Recall initiated by company
26 Nov 2012	Classified by FDA	+581 days
5 Dec 2012	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arizona California Florida Georgia Iowa Illinois Indiana Massachusetts Maryland Michigan Montana North Carolina Nebraska New Jersey New York Ohio Oklahoma Tennessee Texas

Questions about this recall

Is IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com recalled?

Yes. Extremity Medical recalled IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com on 25 Apr 2011. The recall is Class II and its status is Terminated. Recall number Z-0438-2013.

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Extremity Medical

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28 Nov 2012Device	CLASS II	IO Fix IntraOsseous Fixation System recalled by Extremity Medical	Extremity Medical	Other	Nationwide

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