Medical Device Recall: Z-0026-2013

FDA Recalls dataset · Firm: Orthohelix Surgical Designs Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2010-01-29 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0026-2013.

Recall Res Number
Z-0026-2013
Recalling Firm / Manufacturer
FEI Number
3000718467
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2010-01-29
Date Posted
2012-10-09
Date Terminated
2013-02-20
Product Code
HWC
Event Number
54725
Product Quantity
47 Pieces
Product Description 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.

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

Action Details 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.

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.

Code Information / Serial Numbers HSC-056-32-1067051

Related Establishments / Registrations

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