Class 2 Device Recall CranioSculpt C, 10cc, Bone Void Filler

• Date Initiated by Firm: April 03, 2020
• Create Date: May 20, 2020
• Recall Status: Completed
• Recall Number: Z-2054-2020
• Recall Event ID: 85516
• 510(K)Number: K162864
• Product Classification: Methyl methacrylate for cranioplasty - Product Code GXP
• Product: Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger than 25cm2. CRANIO/SCULPT C may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.
• Code Information: Lot 1129289
• Recalling Firm/ Manufacturer: Skeletal Kinetics, Llc; 3885 Arapaho Rd; Addison TX 75001-4314
• For Additional Information Contact: Kathryn A. Jayne; 972-677-4602
• Manufacturer Reason for Recall: Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc.
• FDA Determined Cause: Process design
• Action: The recalling firm notified their customer regarding the medical device recall via email; the recall notice was issued on 04/03/2020. The recalling firm is requesting that affected customers: (1) review the letter in full, review current inventory, and complete and return the Acknowledgement and Receipt Form via email; and (2) return unused inventory via Federal Express (contact the recalling firm for a FedEx shipping account number to cover shipping costs) with reference to Return Material Authorization RMA# 8. If there has been further distribution of the affected devices to other subaccounts, communicate the recall information immediately and conduct a sub-recall to those accounts; request that they immediately cease distribution of the affected devices and return the product. Subsequently, contact the recalling firm for instructions on returning the recalled product received from the subaccounts. Report any adverse health consequences or quality problems experienced with the use of the product to the recalling firm. Events may also be reported to FDA's MedWatch Adverse Event Reporting program online: www.fda.gov/medwatch/report.htm. The following are actions to be taken by Clinical Providers: For a patient that may have been implanted with a product where sterility cannot be assured, it is recommended clinical judgement be used in monitoring and/or treating any potential signs of infection. The firm has initiated the voluntary recall and is requesting that any remaining product from the affected lot be returned. The lot of product was originally returned on November 30, 2018 after a reported complaint was received. The firm confirmed the correct contents of the 76 returned kits and then re-issued the kits on November 30, 2018. The firm has conducted further investigation and is now initiating this recall for the re-issued products. Direct contact information for questions concerning this voluntary recall is the following: Monday-Friday, 8
• Quantity in Commerce: 125 units
• Distribution: US Nationwide distribution in the state of Florida.
• 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.

• 510(K) Database: 510(K)s with Product Code = GXP and Original Applicant = Skeletal Kinetics, LLC.