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U.S. Department of Health and Human Services

Class 2 Device Recall Kelyniam CSI

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  Class 2 Device Recall Kelyniam CSI see related information
Date Initiated by Firm June 10, 2017
Create Date May 14, 2018
Recall Status1 Terminated 3 on September 14, 2020
Recall Number Z-1871-2018
Recall Event ID 79791
510(K)Number K103582  
Product Classification Plate, cranioplasty, preformed, non-alterable - Product Code GXN
Product Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
Code Information Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C.  Case Numbers: CSI082114-CT1 CSI081214-TB1 CSI020216-LK1 CSI092016-LD1R CSI100116-BM1A CSI092616-YB1 CSI092616-MM1 CSI112316-YB1 CSI050217-LS1 CSI052217-AF1 CSI062317-GM1 CSI071017-NS1B CSI071417-CM1 CSI102617-DL1 CSI101617-JF1A CSI102617-DL1 
Recalling Firm/
Manufacturer		 Kelyniam Global, Inc.
97 River Rd
Collinsville CT 06019-3246
For Additional Information Contact Mr. Christ Breault
800-280-8192 Ext. 710
Manufacturer 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
FDA Determined
Cause 2		 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 in Commerce 16
Distribution US nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXN and Original Applicant = KELYNIAM GLOBAL, INC
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