DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defect
Summary
The FDA issued a Class II for DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically c by Musculoskeletal Transplant Foundation, Inc.. Reason: Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery..
Details
Source
Device Recall
External ID
Z-0323-2024
Action Date
2023-11-29
Status
Ongoing
Category
device
Product Description
DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100
Lot/Code Info: GUID: W4184038100T0473 Serial #s: 002220854711400006 002220854711400056 002220854711400003 002220854711400008 002220854711400009 002220854711400001 002220854711400002 002220854711400010 002220854711400011 002220854711400012 002220854711400013 002220854711400014 002220854711400004 002220854711400005 002220854711400007 Exp.Date: June 20, 2025
Quantity Affected: 18 units
Reason for Recall
Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
Distribution
US Nationwide distribution in the states of PA, TX, WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-22
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Musculoskeletal Transplant Foundation, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Musculoskeletal Transplant Foundation, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Musculoskeletal Transplant Foundation, Inc. have FDA actions?
Musculoskeletal Transplant Foundation, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0323-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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