CLASS II Device recall · Reported 3 Apr 2013 · FDA Enforcement Report

Intraosseous Fixation System (IFS) & Cannulated Drill Bit recalled

Orthohelix Surgical Designs is recalling Intraosseous Fixation System (IFS) & Cannulated Drill Bit, distributed nationwide in the US. The recall was initiated on 30 Oct 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart #: IFS-072-17-C, Lot #: 2399041; Part #: IFS-72-20-C, Lot #: 2399051 & Lot #: 2399051R and Part #: IFS-072-25-C, Lot #: 2399061.

Quantity recalledLot # 2399041, 97 pcs; Lot # 2399051, 143 pcs; Lot # 2399051R, 4 pcs & Lot # 2399061, 119 pcs

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-0975-2013
FDA event ID: 64485
Recalling firm: Orthohelix Surgical Designs, Medina, OH
Classification: Class II
Status: Terminated
Recall initiated: 30 Oct 2012
FDA classified: 22 Mar 2013
Reported: 3 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

30 Oct 2012	Recall initiated by company
22 Mar 2013	Classified by FDA	+143 days
3 Apr 2013	Published in enforcement report	+12 days

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

Reason for recall

The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.

Product as listed by the FDA

Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.

Where it was distributed

Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI.

Nationwide California Colorado Illinois Maryland Michigan North Carolina New Mexico Ohio Oklahoma Pennsylvania South Dakota Texas Utah Virginia Washington Wisconsin

Questions about this recall

Why was it recalled?

The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.

Which lots are affected?

Part #: IFS-072-17-C, Lot #: 2399041; Part #: IFS-72-20-C, Lot #: 2399051 & Lot #: 2399051R and Part #: IFS-072-25-C, Lot #: 2399061.

Where was it sold?

Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI.

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 26 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 Orthohelix Surgical Designs

All 4

Reported	Class	Recall	Company	Reason	Where
15 Oct 2014Device	CLASS II	MaxLock Extreme Mod-Foot Concave Reamer recalled	Orthohelix Surgical Designs	Packaging Defects	12 states
17 Oct 2012Device	CLASS II	OrthoHelix Part #Hcs-056-32 Cannulated Hex Driver Non recalled	Orthohelix Surgical Designs	Device Malfunction	Nationwide
17 Oct 2012Device	CLASS II	OrthoHelix Part #Hcs-056-32 Cannulated Hex Driver Non recalled	Orthohelix Surgical Designs	Device Malfunction	Nationwide

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