Device product
putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Z-1056-2022
Product summary
- Firm
- Cerapedics, Inc.
- Event
- Event 90015
- Status
- Terminated
- Classification
- Class III
- Quantity
- 572 units
- Official record key
device-enforcement:Z-1056-2022
Official wording
Reason: Patient chart label contains incorrect Part Number and volume amount.
Code information: Model/Catalog Number: 700-010 UDI Code: (01)00850001680004(17)240531(10)21C0991 Lot Number: 21C0991
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
label contains incorrect