FDA-Device2022-05-18Class III

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

Cerapedics, Inc.
Hazard

Patient chart label contains incorrect Part Number and volume amount.

Sold states
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.
Affected count
572 units
Manufactured in
11025 Dover St Unit 1600, N/A, Westminster, CO, United States
Products
putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1056-2022

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