Recall Z-1455-2015— Musculoskeletal Transplant Foundation, Inc.

Name: FDA recall Z-1455-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-04

Class II · Terminated

Class II FDA medical device recall by Musculoskeletal Transplant Foundation, Inc., initiated 2014-12-04, terminated 2017-05-08. It names one FDA 510(k) clearance: K040262. Product: DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.. Reason: The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact..

Recalling firm: Musculoskeletal Transplant Foundation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-12-04
Terminated: 2017-05-08
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 Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.

Reason for recall

The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact.

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