FDAClass IIApril 29, 2015

DBX Mix recall

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

Why was DBX Mix recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
Recalling firm
Musculoskeletal Transplant Foundation, Inc.
Quantity
25 units
Distribution
US Nationwide distribution to CA, KY, IL, LA, PA, NC, TN, WV, and Puerto Rico.
Recall date
April 29, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls