CLASS II Device recall · Reported 17 Oct 2012 · FDA Enforcement Report

OrthoHelix Part #Hcs-056-32 Cannulated Hex Driver Non recalled

Orthohelix Surgical Designs is recalling OrthoHelix Part #Hcs-056-32 Cannulated Hex Driver Non Sterile Mat: 465 SS The drivers are, distributed nationwide in the US. The recall was initiated on 29 Jan 2010 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesHSC-056-32-1067051

Quantity recalled47 Pieces

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-0026-2013
FDA event ID: 54725
Recalling firm: Orthohelix Surgical Designs, Medina, OH
Classification: Class II
Status: Terminated
Recall initiated: 29 Jan 2010
FDA classified: 9 Oct 2012
Reported: 17 Oct 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

29 Jan 2010	Recall initiated by company
9 Oct 2012	Classified by FDA	+984 days
17 Oct 2012	Published in enforcement report	+8 days

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

Reason for recall

The tips of the drivers are breaking while being used to drive the screws into patients.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Where it was distributed

Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI.

Nationwide California Colorado Florida Georgia Illinois Missouri North Carolina New Hampshire New Jersey New Mexico New York Ohio Oregon Pennsylvania South Dakota Tennessee Texas Virginia Washington Wisconsin

Questions about this recall

Is OrthoHelix Part #Hcs-056-32 Cannulated Hex Driver Non Sterile Mat: 465 SS The drivers are recalled?

Yes. Orthohelix Surgical Designs recalled OrthoHelix Part #Hcs-056-32 Cannulated Hex Driver Non Sterile Mat: 465 SS The drivers are on 29 Jan 2010. The recall is Class II and its status is Terminated. Recall number Z-0026-2013.

Why was it recalled?

The tips of the drivers are breaking while being used to drive the screws into patients.

Which lots are affected?

HSC-056-32-1067051

Where was it sold?

Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, 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 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 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
3 Apr 2013Device	CLASS II	Intraosseous Fixation System (IFS) & Cannulated Drill Bit recalled	Orthohelix Surgical Designs	Other	Nationwide
17 Oct 2012Device	CLASS II	OrthoHelix Part #Hcs-056-32 Cannulated Hex Driver Non recalled	Orthohelix Surgical Designs	Sterility	Nationwide

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