Events

Recall of Device Recall Manta Ray" Anterior Cervical Plate (ACP) System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences 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
    58167
  • Event Risk Class
    Class 2
  • Event Number
    Z-2197-2011
  • Event Initiated Date
    2011-01-10
  • Event Date Posted
    2011-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98587
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Reason
    Based upon the results of the firm's literature review, they determined that the package insert (information for use) and information in the surgical technique should be revised to include additional warnings, precautions and possible adverse events.
  • Action
    The firm, Integra Spine, sent an "URGENT: FIELD CORRECTIVE ACTION" letter dated January 10, 2011 with a Field Corrective Action Acknowledgement and Return Form sent via Fed Ex/ priority mail to all customers including physicians and distributors. The letter describes the product, problem and actions to be taken. The customers were instructed to review the current inventory to identify product from the affected part numbers; replace the existing IFU (22-PI-01 rev C) with the revised IFU (22-PI-01 rev D) and the existing Surgical Technique (ST-22-001 rev A) with the revised Surgical Technique (ST-22-001 rev B), and complete and return the Field Corrective Action Acknowledgement and Return Form via fax to: 877-558-6227 or email. If you have any additional questions, contact the Manager Quality Systems Integra Spine at 330-475-8646.

Device

Device Recall Manta Ray" Anterior Cervical Plate (ACP) System
  • Model / Serial
    Part Numbers: 22-10-0118, 22-10-0120, 22-10-0122, 22-10-0124, 22-10-0126, 22-10-0128, 22-10-0130, 22-10-0132, 22-10-0134, 22-10-0231, 22-10-0234, 22-10-0237, 22-10-0240, 22-10-0243, 22-10-0246, 22-10-0249, 22-10-0252, 22-10-348, 22-10-0351, 22-10-0354, 22-10-0357, 22-10-0360, 22-10-0363, 22-10-0366, 22-10-0369, 22-10-0372, 22-10-0375, 22-10-0468, 22-10-0472, 22-10-0476, 22-10-0480, 22-10-0484, 22-10-0488, 22-12-4014, 22-12-4015, 22-12-4016, 22-12-018, 22-13-4513, 22-13-4515, 22-13-4517, 22-14-4513, 22-14-4515, 22-14-4517, 22-15-4010, 22-15-4012, 22-15-4013, 22-15-4014, 22-15-4015, 22-15-4016, 22-5-4018, 22-16-4010, 22-16-4012, 22-16-4013, 22-16-4014, 22-16-4015, 22-16-4016, 22-16-4018, 22-17-4513, 22-17-4515, 22-17-4517, 22-18-4513, 22-18-4515, 22-18-4517, 22-20-0118, 22-20-0120, 22-20-0122, 22-20-0124, 22-20-0126, 22-20-0128, 22-20-0130, 22-20-0132, 22-20-0134, 22-20-0231, 22-20-0234, 22-20-0237, 22-20-0240, 22-20-0243, 22-20-0246, 22-20-0249, 22-20-0252, 22-20-0348, 22-20-0351, 22-20-0354, 22-20-0357, 22-20-0360, 22-20-0363, 22-20-0366, 22-20-0369, 22-20-0372, 22-20-0375, 22-20-0468, 22-20-0472, 22-20-0476, 22-20-0480, 22-20-0484, 22-20-0488, 22-20-0492, 22-21-4010, 22-21-4011, 22-21-4012, 22-21-4013 & 22-21-4014.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: USA including states of: AL, AZ, CA, CO, FL, GA, ID. IL, KS, LA, MD, MO, NH, NM, NV, NY, OH, OK, OR, PA, PR, SD, TN, TX, UT, VA, WI, and WV.
  • Product Description
    Manta Ray" Anterior Cervical Plate (ACP) System, || Intended use: The Manta Ray ACP System is an anterior cervical plate that is indicated for temporary stabilization of the cervical spine from C2-C7.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.