Medical device recalls Moderate risk

Musculoskeletal Transplant Foundation, Inc. recalls DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defec…

Recall date
September 22, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0323-2024
FDA classification
Class II
Brand / firm
Musculoskeletal Transplant Foundation, Inc.
Sold / distributed
US Nationwide distribution in the states of PA, TX, WA.

Why it was recalled

Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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