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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-1872-2018
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-IM1003
Code Information 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 
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 23
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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