OrthoHelix Part #HCS-056-32 3.8MM 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.
FDA Recall Z-0027-2013 · Posted 2012-10-09
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Recalling FirmOrthohelix Surgical Designs Inc
Recall StatusTerminated
Product CodeHWC
Date Initiated2010-01-29
Date Terminated2013-02-20
Product Quantity120 Pieces
Reason for Recall
The tips of the drivers are breaking while being used to drive the screws into patients.
Firm 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.
Root Cause
Software design (manufacturing process)
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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