Recall Z-0323-2024— Musculoskeletal Transplant Foundation, Inc.

Name: FDA recall Z-0323-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-22

Class II · Ongoing

Class II FDA medical device recall by Musculoskeletal Transplant Foundation, Inc., initiated 2023-09-22. It names one FDA 510(k) clearance: K040262. Product: 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: Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery..

Recalling firm: Musculoskeletal Transplant Foundation, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-09-22
Firm location: Edison, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K040262 — DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIXMusculoskeletal Transplant Foundation·cleared 2005-03-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.