putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
- Company
- Cerapedics, Inc.
- Recall Initiated
- April 14, 2022
- Terminated
- December 23, 2024
- Recall Number
- Z-1056-2022
- Quantity
- 572 units
- Firm Location
- Westminster, CO
Reason for Recall
Patient chart label contains incorrect Part Number and volume amount.
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 / Code Info
Model/Catalog Number: 700-010 UDI Code: (01)00850001680004(17)240531(10)21C0991 Lot Number: 21C0991
Root Cause
Under Investigation by firm
Action Taken
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.