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U.S. Department of Health and Human Services

Class 3 Device Recall iFACTOR Peptide Enhanced Bone Graft Putty

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  Class 3 Device Recall iFACTOR Peptide Enhanced Bone Graft Putty see related information
Date Initiated by Firm April 14, 2022
Create Date May 10, 2022
Recall Status1 Open3, Classified
Recall Number Z-1056-2022
Recall Event ID 90015
PMA Number P140019 
Product Classification Filler, bone void, synthetic peptide - Product Code NOX
Product putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Code Information Model/Catalog Number: 700-010 UDI Code: (01)00850001680004(17)240531(10)21C0991 Lot Number: 21C0991
Recalling Firm/
Manufacturer		 Cerapedics, Inc.
11025 Dover St Unit 1600
Westminster CO 80021-5574
For Additional Information Contact Rebecca Helpert
303-974-6275
Manufacturer Reason
for Recall		 Patient chart label contains incorrect Part Number and volume amount.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 04/14/2022, Cerapedics, Inc. email a "Medical Device Recall" letter to customer informing them that the firm is voluntarily recalling all units of i-FACTOR 1.0cc Putty from lot 21C0991 due to the incorrect product code on the patient chart label. Customers are asked to: 1) Examine their inventory and return any remaining units from lot 21C0991 using the provided RMA number. 2) Respond to the Recall email or call toll free at 1-866-360-5612 to report the number of units at their location. 3) If the affected product has been further distributed, notify those customers of the recall utilizing the recall notification letter. Questions or assistance - contact Customer Service at 1-866-360-5612.
Quantity in Commerce 572 units
Distribution U.S. Nationwide distribution in the states of AL, AZ, CA, CT, DC, DE, ID, IN, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, TX, VA, and WA.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = NOX and Original Applicant = CERAPEDICS, LLC
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