Z-1056-2022Class III

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

Name: Z-1056-2022 putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Creator: Cerapedics, Inc.
Published: 2022-04-14
License: https://open.fda.gov/license/

Cerapedics, Inc. / initiated 2022-04-14 / Terminated / root cause: labeling and UDI

FDA source

Cerapedics, Inc. began a recall of putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY on 2022-04-14. FDA classified it as Class III and gives the reason as "Patient chart label contains incorrect Part Number and volume amount". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1056-2022
Classification: Class III
Status: Terminated
Initiated: 2022-04-14
Posted: 2022-05-10
Terminated: 2024-12-23
Recalling firm: Cerapedics, Inc.
Product: putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Product code: NOX Filler, Bone Void, Synthetic Peptide
Reason for recall: Patient chart label contains incorrect Part Number and volume amount.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Model/Catalog Number: 700-010 UDI Code: (01)00850001680004(17)240531(10)21C0991 Lot Number: 21C0991

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1056-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1056-2022	Class III	Terminated	Voluntary: Firm initiated	2022-05-18	2022-05-10

Product code NOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)