Events

Recall of Device Recall Response 5.5/6.0 Spine System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by OrthoPediatrics Corp.

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
    72962
  • Event Risk Class
    Class 2
  • Event Number
    Z-0622-2016
  • Event Initiated Date
    2015-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142594
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Reason
    Response spine uniaxial pedicle & uniaxial reduction pedicle screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.
  • Action
    The firm, OrthoPediatrics Corp., sent an "URGENT MEDICAL DEVICE RECALL" letter dated 11/13/2015 to affected customers via email. The letter included a description of the reason for the recall, affected product, consignee responsibilities, and actions to be taken. The customers were instructed to take immediate possession of all the identified devices; quarantine them and immediately return them to OrthoPediatrics, and complete and return the Mandatory Reply Form via fax to (574) 269-3692 or email: MF0x@OrthoPediatrics.com. If you have any questions, please contact VP-Regulatory Affairs (574) 268-6379 or email: mfox@orthopediatrics.com.

Device

Device Recall Response 5.5/6.0 Spine System
  • Model / Serial
    Item number; lot; product description  00-1300-1735; 44003; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 35MM. 00-1300-0735; 44601; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM. 00-1300-0740; 44602; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0740; 43926; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0740; 44252; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0745; 43927; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM. 00-1300-0750; 44619; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 50MM. 00-1300-0620; 44623; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 20MM. 00-1300-0640; 44617; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM. 00-1300-0640; 44884; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM. 00-1300-1745; 44005; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 45MM. 00-1300-0635; 44677; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 35MM.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to states of: AL, AZ, CA, DE, FL, GA, HI, KY, LA, MI, MO, MN, MS, NC, NJ, NY, OH, OR, TN, and TX.
  • Product Description
    UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw || The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
  • Manufacturer
    OrthoPediatrics Corp

Manufacturer

OrthoPediatrics Corp
  • Manufacturer Address
    OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
  • Manufacturer Parent Company (2017)
    Orthopediatrics Corp
  • Source
    USFDA