FDA Medical Device Recalls (openFDA)
Kelyniam Global, Inc.: Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
- Recall number
- Z-1872-2018
- Recalling firm
- Kelyniam Global, Inc.
- Product
- Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
- Status
- Terminated
- Initiated
- 2017-06-10
- Posted
- not on file
- Terminated
- 2020-09-14
- 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
- Root cause
- Device Design
- 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.
- Quantity
- 23
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K103582"]
- PMA numbers
- not on file
- Product code
- GXN
- Firm FEI
- 3009424796
- Firm city
- Collinsville
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28