DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100
Reported: November 29, 2023 Initiated: September 22, 2023 #Z-0323-2024
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
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.
Details
- Recalling Firm
- Musculoskeletal Transplant Foundation, Inc.
- Units Affected
- 18 units
- Distribution
- US Nationwide distribution in the states of PA, TX, WA.
- Location
- Edison, NJ
Frequently Asked Questions
What product was recalled? ▼
DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100. Recalled by Musculoskeletal Transplant Foundation, Inc.. Units affected: 18 units.
Why was this product recalled? ▼
Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2023. Severity: Moderate. Recall number: Z-0323-2024.
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