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-1873-2018
  • 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=163450
  • 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: CSI070314-JF1 CSI082214-EC1 CSI090314-CG1 CSI091614-JB1 CSI101414-RA1 CSI110514-SS2 CSI120814-JC1 CSI121114-DD1 CSI121614-LG1 CSI121714-OL1 CSI011615-AC1 CSI012915-JG1 CSI012915-SS1 CSI022415-HL1 CSI040615-RA1 CSI060115-EB1 CSI102215-CT1 CSI112415-ES1 CSI101615-BE1 CSI012016-RT1B CSI022916-CS1 CSI032216-SP1 CSI020216-JR1 CSI051716-TM1 CSI070516-AT1 CSI070116-EG1 CSI072816-JE1 CSI092716-AV1 CSI101416-TY1 CSI110816-CS1 CSI112316-NK1 CSI092616-CB1 CSI111516-RB1 CSI113016-NR1 CSI111616-FH1 CSI010517-JH1 CSI041417-KK1 CSI060117-AR1 CSI062617-LV1 CSI071017-NS1A CSI081717-GG1 CSI081717-JM1 CSI082717-LH1 CSI082917-UK1 CSI081717-JM1 CSI090617-JH2 CSI092717-DH1 CSI092617-OT1 CSI100417-EZ1 CSI100517-AE1 CSI100617-MH1 CSI101817-KD1 CSI102617-NK1 CSI101617-JF1B
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution.
  • Product Description
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
  • 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