The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0026-2013·Announced 2012-10-17

OrthoHelix 3.2mm Cannulated Hex Driver Recall Due to Tip Breakage

Orthohelix Surgical Designs Inc is recalling 47 non-sterile 3.2mm cannulated hex drivers because their tips are breaking while driving screws into patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (tip breakage) in a medical device used during surgery, which meets the criteria for a Severe rating due to the risk of significant injury.

Plain-English summary

Orthohelix Surgical Designs Inc is recalling 47 pieces of the OrthoHelix Part #HCS-056-32 3.2mm Cannulated Hex Driver. These non-sterile drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, foot, and ankle.

The recall was initiated because the tips of the drivers are breaking while being used to drive the screws into patients. The affected units were distributed nationwide in the United States, 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.

Healthcare facilities and users should stop using the affected drivers and contact Orthohelix Surgical Designs Inc for further instructions.

The recalled product

Product
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…
Manufacturer
Orthohelix Surgical Designs Inc
Category
Medical Device — Surgical Instrument
Hazard
Affected units
47

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • HSC-056-32-1067051

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Orthohelix Surgical Designs Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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