Events

Recall of Device Recall Kelyniam CSI

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kelyniam Global, 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
    79791
  • Event Risk Class
    Class 2
  • Event Number
    Z-1872-2018
  • Event Initiated Date
    2017-06-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163449
  • 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
    Plate, cranioplasty, preformed, non-alterable - Product Code GXN
  • Reason
    Significant design changes made to the custom skull implant (csi) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to fda for marketing clearance. the temporal suture system (tss) is no longer being offered and the integrated fixation system (ifs) has been temporarily suspended.
  • Action
    On June 10, 2017, the recalling firm notified its Sales Representatives that effective June 10, 2017, the firm would no longer offer the temporal suture system (TSS). The firm requested that sales reps dispose of all marketing materials which contain details regarding the TSS. Sales reps who wanted to keep existing booklets in the field were asked to contact the firm to obtain adhesive labels to place over the discontinued product. On November 13, 2017, the recalling firm notified its Sales Representatives that the firm was temporarily suspending shipment of the Integrated Fixation System (IFS). The firm stated that all paper brochures were to be discarded, and asked sales reps to inform all those who received "Customize Skull and Craniofacial Implants" brochure and IFU. Revised marketing materials are available on the firm's website, www.kelyniam.com. If you have any questions, you may contact Dr. Mark V. Smith, Vice President of Kelyniam Global, Inc., at msmith@kelyniam.com, or by phone at (800) 280-8192 x702.

Device

Device Recall Kelyniam CSI
  • Model / Serial
    Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C.  Case Numbers: CSI111715-KH1 CSI072814-JB1 CSI082514-MA1 CSI080714-CT1 CSI091914-JW1 CSI101614-TR1 CSI041415-MZ1 CSI100915-DD1 CSI120215-MM1 CSI100915-DD2 CSI011816-TA1 CSI012016-RT1A CSI012716-MP1 CSI021116-CA1 CSI030716-BC1 CSI040716-CK1 CSI060916-DF1 CSI070716-AC1 CSI092116-JA1 CSI110416-DW1 CSI120616-LS1 CSI012417-SD1 CSI062617-HR1
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution.
  • Product Description
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
  • Manufacturer
    Kelyniam Global, Inc.

Manufacturer

Kelyniam Global, Inc.
  • Manufacturer Address
    Kelyniam Global, Inc., 97 River Rd, Collinsville CT 06019-3246
  • Manufacturer Parent Company (2017)
    Kelyniam Global, Inc.
  • Source
    USFDA