Events

Recall of ExoShape Soft Tissue Fastener 12 mm x 30 mm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medshape Solutions, 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
    64988
  • Event Risk Class
    Class 2
  • Event Number
    Z-1276-2013
  • Event Initiated Date
    2013-04-04
  • Event Date Posted
    2013-05-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117586
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Reason
    Expiration date on the patient label and date on the product carton were not the same.
  • Action
    Medshape sent an "URGENT: MEDICAL DEVICE RECALL" letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Device

ExoShape Soft Tissue Fastener 12 mm x 30 mm
  • Model / Serial
    Lot No. 113011-002
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.
  • Product Description
    ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. || For use in the fixation of ligaments, tendons or soft tissue grafts to bone.
  • Manufacturer
    Medshape Solutions, INC.

Manufacturer

Medshape Solutions, INC.
  • Manufacturer Address
    Medshape Solutions, INC., 1575 Northside Dr Nw Ste 440, Atlanta GA 30318-4211
  • Manufacturer Parent Company (2017)
    MedShape Inc.
  • Source
    USFDA