Recall Z-1056-2022 ยท NOX Filler, Bone Void, Synthetic Peptide
Cerapedics, Inc.
putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
| Date | Apr 14, 2022 |
| Status | Terminated |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.