Z-0026-2013Class II

OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive...

Name: Z-0026-2013 OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive...
Creator: Orthohelix Surgical Designs Inc
Published: 2010-01-29
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2010-01-29 / Terminated / root cause: software

FDA source

Orthohelix Surgical Designs Inc began a recall of 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... on 2010-01-29. FDA classified it as Class II and gives the reason as "The tips of the drivers are breaking while being used to drive the screws into patients". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0026-2013
Classification: Class II
Status: Terminated
Initiated: 2010-01-29
Posted: 2012-10-09
Terminated: 2013-02-20
Recalling firm: TORNIER Inc.
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 hand, wrist, afoot, and ankle.
Product code: HWC Screw, Fixation, Bone
Reason for recall: The tips of the drivers are breaking while being used to drive the screws into patients.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: The firm, OrthoHelix Surgical Designs, Inc., sent an "IMPORTANT RECALL NOTICE: Mini MaxTorque HCS-056-32 & HCS-056-38 Drivers" dated January 29, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue the use of these drivers immediately and return them to OrthoHelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina, OH 44256; ATTN: Driver Recall. Should you have any questions about system, call 330-247-1145 or the Director of Regulatory Affairs & Quality Assurance at 330-247-1444.
Quantity in commerce: 47 Pieces
Distribution: 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.
Product codes and lots: HSC-056-32-1067051

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0026-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0026-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09
Z-0027-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09

Product code HWC

K082574Class IIMaxtorque Mini Cannulated Screw SystemOrthohelix Surgical Designs, Inc. / cleared 2008-12-08

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)