FDAClass IIIMay 18, 2022

putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc recall

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

Why was putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc recalled?

Patient chart label contains incorrect Part Number and volume amount.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Recalling firm
Cerapedics, Inc.
Quantity
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.
Recall date
May 18, 2022
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls