Z-1056-2022 Class III Terminated

Recalled by Cerapedics, Inc. — Westminster, CO

Recall Details

Product Type
Devices
Report Date
May 18, 2022
Initiation Date
April 14, 2022
Termination Date
December 23, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
572 units

Product Description

putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY

Reason for Recall

Patient chart label contains incorrect Part Number and volume amount.

Distribution Pattern

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.

Code Information

Model/Catalog Number: 700-010 UDI Code: (01)00850001680004(17)240531(10)21C0991 Lot Number: 21C0991