CLASS II Device recall · Reported 6 Feb 2013 · FDA Enforcement Report

IO FiX System Accessory recalled by Extremity Medical

Extremity Medical is recalling Extremity Medical, IO FiX System Accessory, distributed nationwide in the US. The recall was initiated on 22 Mar 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number 101-00010 Lot number AP3V12 AP4E01 AP4N04 AP5E25 AP6A44 AP6E42 AP6L14 AP6M17 AP6T08

Quantity recalled93 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-0752-2013
FDA event ID: 63805
Recalling firm: Extremity Medical, Parsippany, NJ
Classification: Class II
Status: Terminated
Recall initiated: 22 Mar 2012
FDA classified: 30 Jan 2013
Reported: 6 Feb 2013
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Lead & Heavy Metals
Device type: Heart & Vascular Devices

Timeline

22 Mar 2012	Recall initiated by company
30 Jan 2013	Classified by FDA	+314 days
6 Feb 2013	Published in enforcement report	+7 days

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

Reason for recall

Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic device.

Where it was distributed

Worldwide Distribution -- Nationwide Distribution including the states of AR, AZ, CA, FL, GA, IL, IN, MD, MT, NC, NE, NH, NJ, NY, OH, PA, TN, TX, WI and WA.

Nationwide Arkansas Arizona California Florida Georgia Illinois Indiana Maryland Montana North Carolina Nebraska New Hampshire New Jersey New York Ohio Pennsylvania Tennessee Texas Washington Wisconsin

Questions about this recall

Is IO FiX System Accessory recalled?

Yes. Extremity Medical recalled IO FiX System Accessory on 22 Mar 2012. The recall is Class II and its status is Terminated. Recall number Z-0752-2013.

Why was it recalled?

Which lots are affected?

Catalog Number 101-00010 Lot number AP3V12 AP4E01 AP4N04 AP5E25 AP6A44 AP6E42 AP6L14 AP6M17 AP6T08

Where was it sold?

Worldwide Distribution -- Nationwide Distribution including the states of AR, AZ, CA, FL, GA, IL, IN, MD, MT, NC, NE, NH, NJ, NY, OH, PA, TN, TX, WI and WA.

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

All 4

Reported	Class	Recall	Company	Reason	Where
27 Mar 2013Device	CLASS II	Disposable Orthopedic Surgical Instrument - Guidewire recalled	Extremity Medical	Sterility	14 states
5 Dec 2012Device	CLASS II	IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com recalled	Extremity Medical	Other	Nationwide
28 Nov 2012Device	CLASS II	IO Fix IntraOsseous Fixation System recalled by Extremity Medical	Extremity Medical	Other	Nationwide

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