FDA Medical Device Recalls (openFDA)
Cerapedics, Inc.: putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
- Recall number
- Z-1056-2022
- Recalling firm
- Cerapedics, Inc.
- Product
- putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
- Status
- Terminated
- Initiated
- 2022-04-14
- Posted
- not on file
- Terminated
- 2024-12-23
- Reason
- Patient chart label contains incorrect Part Number and volume amount.
- 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
- 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.
- Lot, serial or model codes
- Model/Catalog Number: 700-010 UDI Code: (01)00850001680004(17)240531(10)21C0991 Lot Number: 21C0991
- 510(k) numbers
- not on file
- PMA numbers
- ["P140019"]
- Product code
- NOX
- Firm FEI
- 3007155473
- Firm city
- Westminster
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28