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Terminated

DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.

FDA Recall Z-1455-2015 · Posted 2015-04-17

Recalling FirmMusculoskeletal Transplant Foundation, Inc.
Recall StatusTerminated
Product CodeMQV
Date Initiated2014-12-04
Date Terminated2017-05-08
Product Quantity25 units

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.

Firm Action

MTF notified their customers on 12/4/2014 and 12/8/2014 via phone and letter.

Root Cause

Packaging process control

Distribution Pattern

US Nationwide distribution to CA, KY, IL, LA, PA, NC, TN, WV, and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040262DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIXMusculoskeletal Transplant Foundation · 2005-03-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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