Z-1870-2018Class II

Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)

Name: Z-1870-2018 Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Creator: Kelyniam Global, Inc.
Published: 2017-06-10
License: https://open.fda.gov/license/

Kelyniam Global, Inc. / initiated 2017-06-10 / Terminated / root cause: design

FDA source

Kelyniam Global, Inc. began a recall of Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) on 2017-06-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1870-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-10
Posted: 2018-05-14
Terminated: 2020-09-14
Recalling firm: Kelyniam Global, Inc.
Product: Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Product code: GXN Plate, Cranioplasty, Preformed, Non-Alterable
Reason for recall: 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 tag: design
FDA 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 [email protected], or by phone at (800) 280-8192 x702.
Quantity in commerce: 2
Distribution: US nationwide distribution.
Product codes and lots: Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C. Case Numbers: CSI041216-CM1 CSI092016-LD1L

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1870-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1870-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-14
Z-1871-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-14
Z-1872-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-14
Z-1873-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-14

Product code GXN

K103582Class IIKelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. / cleared 2011-04-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)