Events

Recall of Device Recall MotoCLIP(TM) Super Elastic Fusion System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Crossroads Extremity Systems Llc.

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
    76687
  • Event Risk Class
    Class 2
  • Event Number
    Z-1487-2017
  • Event Initiated Date
    2017-02-16
  • Event Date Posted
    2017-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153844
  • 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
    Staple, fixation, bone - Product Code JDR
  • Reason
    Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.
  • Action
    The firm notified their distributors by email on 02/16-17/2017. The distributors were asked to return the unused lot #101866. The firm also contacted the implanting surgeons either by visit or telephone about the potential for an incorrect size of the implant and asked if there were any adverse events.

Device

Device Recall MotoCLIP(TM) Super Elastic Fusion System
  • Model / Serial
    Lot Number 101868
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Al, FL, IN, Il, NE, TX, NM, CO, AZ
  • Product Description
    MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
  • Manufacturer
    Crossroads Extremity Systems Llc

Manufacturer

Crossroads Extremity Systems Llc
  • Manufacturer Address
    Crossroads Extremity Systems Llc, 6055 Primacy Pkwy Ste 140, Memphis TN 38119-5702
  • Source
    USFDA