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Z-1056-2022 Class III Terminated

Recalled by Cerapedics, Inc. — Westminster, CO

FDA device recall Z-1056-2022 was initiated by Cerapedics, Inc. on April 14, 2022 and is designated Class III. Reason for recall: Patient chart label contains incorrect Part Number and volume amount. The recall status is terminated (terminated December 23, 2024). Affected quantity: 572 units.

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