Events

Recall of Device Recall MAXLOCK EXTREME EXTREMITY PLATING SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthohelix Surgical Designs Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60454
  • Event Risk Class
    Class 2
  • Event Number
    Z-0421-2012
  • Event Initiated Date
    2011-08-22
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105467
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Plate, fixation, bone - Product Code HRS
  • Reason
    The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing.
  • Action
    Orthohelix Surgical Designs Inc. sent an URGENT RECALL NOTIFICATION letter dated August 22, 2011 to all affected customers. The letter identified the affected products, the problem, and the actions to be taken. Customers were instructed to immediately inventory, remove and return the recalled product to the firm via FedEx or any shipping method with tracking capability. Customers were also requested to notify any affected user facilities of the recall. For any questions call 330-247-1444 or 330-247-1445.

Device

Device Recall MAXLOCK EXTREME EXTREMITY PLATING SYSTEM
  • Model / Serial
    Lot # 1364, 1731, 1862, Model # VAR-031-35-10, Model # VAR-031-35-12, Model # VAR-031-35-14, Model # VAR-031-35-16, Model # VAR-031-35-18, Model # VAR-031-35-20, Model # VAR-031-35-22, Model # VAR-031-35-24, Model #, VAR-031-35-26, Model # VAR-031-35-28, Model # VAR-031-35-30 & Lot # 1365011, 1365012, Model #, MXL-032-35 and Model # VAR-032-35
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution (USA) - including the states of: CA, CO, CT, FL, GA, IA, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI and WY.
  • Product Description
    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.
  • Manufacturer
    Orthohelix Surgical Designs Inc

Manufacturer

Orthohelix Surgical Designs Inc
  • Manufacturer Address
    Orthohelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina OH 44256
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA