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Recall Observatory FDA recall evidence

Device product

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

Z-1455-2015

December 04, 2014

Class II

Product summary

Firm
Musculoskeletal Transplant Foundation, Inc.
Event
Event 70739
Status
Terminated
Classification
Class II
Quantity
25 units
Official record key
device-enforcement:Z-1455-2015

Official wording

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

Code information: 064130067910690008; 064130067910690009; 064130067910690004; 064130067910690023; 064130067910690024 064130067910690005; 064130067910690015; 064130067910690016; 064130067910690018; 064130067910690020; 064130067910690007; 064130067910690013; 064130067910690028; 064130067910690029; 064130067910690030; 064130067910690010; 064130067910690006; 064130067910690011; 064130067910690012; 064130067910690019; 064130067910690021; 064130067910690014; 064130067910690017; 064130067910690001; 064130067910690022

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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