Events

Recall of Device Recall Manta Ray ACP System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Theken Spine 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
    56502
  • Event Risk Class
    Class 2
  • Event Number
    Z-0087-2011
  • Event Initiated Date
    2010-07-29
  • Event Date Posted
    2010-10-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93807
  • 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
    The manta ray cervical system was subject to corrective action by the firm after two (2) customer complaints were received alleging that screws were 'backing out' of the device during surgical procedures.
  • Action
    Integra sent a Technical Bulletin dated July 29, 2010 via Fedex to their customers. The bulletin identified the product, the problem, and action to be taken by the user/customers (surgeons) of the two (2) reported instances of screws backing out of the plates. The Bulletin provided instructions outlining the proper surgical techniques for implantation of screws using the Manta Ray ACP System. The bulletin also included an attached acknowledgement form which the user/customers were asked to complete and FAX to (609) 275-5363 or E-mail back to the E-mail address provided. The form verified that each customer: 1) received the technical bulletin; and 2) has read and understood the proper technique for surgical placement of the screws as outlined in the bulletin. For technical support customers were to contact the Customer Service Department at (866) 942-8698.

Device

Device Recall Manta Ray ACP System
  • Model / Serial
    A total of 136 Catalog Numbers of the suspect device were affected by the firm's corrective action. They are as follows:   22-10-0118 22-10-0366 22-12-4016 22-17-4515 22-20-0351 22-21-4017 22-10-0120 22-10-0369 22-12-4018 22-17-4517 22-20-0354 22-21-4018 22-10-0122 22-10-0372 22-13-4513 22-18-4513 22-20-0357 22-22-4511 22-10-0124 22-10-0375 22-13-4515 22-18-4515 22-20-0360 22-22-4513 22-10-0126 22-10-0468 22-13-4517 22-18-4517 22-20-0363 22-22-4515 22-10-0128 22-10-0472 22-14-4513 22-20-0118 22-20-0366 22-22-4517 22-10-0130 22-10-0476 22-14-4515 22-20-0120 22-20-0369 22-22-4519 22-10-0132 22-10-0480 22-14-4517 22-20-0122 22-20-0372 22-23-4010 22-10-0134 22-10-0484 22-15-4010 22-20-0124 22-20-0375 22-23-4011 22-10-0231 22-10-0488 22-15-4012 22-20-0126 22-20-0468 22-23-4012 22-10-0234 22-10-0492 22-15-4013 22-20-0128 22-20-0472 22-23-4013 22-10-0237 22-11-4010 22-15-4014 22-20-0130 22-20-0476 22-23-4014 22-10-0240 22-11-4012 22-15-4015 22-20-0132 22-20-0480 22-23-4015 22-10-0243 22-11-4013 22-15-4016 22-20-0134 22-20-0484 22-23-4016 22-10-0246 22-11-4014 22-15-4018 22-20-0231 22-20-0488 22-23-4017 22-10-0249 22-11-4015 22-16-4010 22-20-0234 22-20-0492 22-23-4018 22-10-0252 22-11-4016 22-16-4012 22-20-0237 22-21-4010 22-24-4511 22-10-0348 22-11-4018 22-16-4013 22-20-0240 22-21-4011 22-24-4513 22-10-0351 22-12-4010 22-16-4014 22-20-0243 22-21-4012 22-24-4515 22-10-0354 22-12-4012 22-16-4015 22-20-0246 22-21-4013 22-24-4517 22-10-0357 22-12-4013 22-16-4016 22-20-0249 22-21-4014 22-24-4519 22-10-0360 22-12-4014 22-16-4018 22-20-0252 22-21-4015  22-10-0363 22-12-4015 22-17-4513 22-20-0348 22-21-4016
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - USA including AL, AZ, CA, CT, FL, GA, HI, IL, ID, IN, KS, LA, MI, MD, MN, MA, MD, MS, NE, NY, NC, NJ, NV, NM, OH, OR, OK, PA, TN, TX, UT, WI, and WA.WA.
  • Product Description
    Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1. || Manta Ray Anterior Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion.
  • Manufacturer
    Theken Spine Llc

Manufacturer

Theken Spine Llc
  • Manufacturer Address
    Theken Spine Llc, 1800 Triplett Blvd, Akron OH 44306-3311
  • Manufacturer Parent Company (2017)
    Theken Spine Llc
  • Source
    USFDA