putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Summary
The FDA issued a Class III for putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY by Cerapedics, Inc.. Reason: Patient chart label contains incorrect Part Number and volume amount..
Details
Source
Device Recall
External ID
Z-1056-2022
Action Date
2022-05-18
Status
Terminated
Category
device
Product Description
putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Lot/Code Info: Model/Catalog Number: 700-010 UDI Code: (01)00850001680004(17)240531(10)21C0991 Lot Number: 21C0991
Quantity Affected: 572 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-14
Company
Westminster, CO
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cerapedics, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cerapedics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cerapedics, Inc. have FDA actions?
Cerapedics, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1056-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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