BEUDAMED
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    Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.

    FDA Recall
    Terminated ·Surgical Design Inc·Product code HFX·January 26, 2011

    MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System.

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HRS·November 1, 2005

    MaxTorque Cannulated Screw Model # MSD-010-55-060S

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HWC·April 7, 2009

    DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS: 6 stainless steel plates (2-lefts, 2-rights, and 1-right long and 1-right left), 48 distal locking-screws (ranging from 10-24mm), 32 distal locking pegs, 36 proximal locking screws, 24 proximal non-locking screws. INSTRUMENTS: 2 Bending Pliers*, 1 Bone Reduction Forcep*, 2 Hohmann Retractors *, 1 Ratchet Handle*, 1 Periosteal Elevator*, 1 Dingman Elevator *, 1 K & K Elevator *, four Driver tips *, five drill guides*, 2-1.6 Drill Bits *, 2-2.3 Drill Bits *, 1 Plate Holder Verbruge *, 2 Depth Gages *, 6 K wires.

    FDA Recall
    Terminated ·OrthoHelix Surgical Designs Inc·Product code HRS·August 3, 2006

    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
    Terminated ·Orthohelix Surgical Designs Inc·Product code HWC·January 29, 2010

    Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HWC·March 23, 2010

    CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HWX·October 15, 2010

    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.

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HWC·January 29, 2010

    DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, DRV-002-1L, Fixed Standard Left Plate, and DRV-002-1R, Fixed Standard Right Plate; Distal Screw Part Numbers: DRV-021-24-10, -12, -14, -16, -18, -20, -22 and -24; Distal Peg Part Number: DRV-121-20-10, -12, -14, -16, -18, -20, -22, and -24; All screw caddies and any distal screw and peg inventory not yet added to screw caddies, Ortho Helix Surgical Designs, Inc., Akron, OH

    FDA Recall
    Terminated ·OrthoHelix Surgical Designs Inc·Product code HRS·September 4, 2007

    CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HWX·October 15, 2010

    MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code LXH·September 19, 2014

    MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HRS·August 22, 2011

    Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH The intended use: Used to stabilize and aid in the fixation of fractures, fusions, and osteotomies.

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code LXH·October 16, 2009

    Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. Used to drill or cut bone prior to implantation of screws

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HTW·September 3, 2009

    CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HWX·October 15, 2010

    Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901, Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. Surgical Case and Tray Delivery System used to house plating and screw orthopedic implant system and instrumentation.

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HRS·July 6, 2011

    Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HTW·October 30, 2012

    Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.

    FDA Enforcement
    Class II ·Terminated·Orthohelix Surgical Designs Inc·April 3, 2013

    MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.

    FDA Enforcement
    Class II ·Terminated·Orthohelix Surgical Designs Inc·October 15, 2014

    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.

    FDA Enforcement
    Class II ·Terminated·Orthohelix Surgical Designs Inc·October 17, 2012