FDA recall Z-1056-2022

Product

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

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.

Key facts

Status

Terminated

Initiation date

2022-04-14

Report date

2022-05-18

Termination date

2024-12-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Westminster, CO, United States

Primary source

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