DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
This recall has been terminated (originally issued April 17, 2015).
- Recall Initiated
- December 4, 2014
- Posted
- April 17, 2015
- Terminated
- May 8, 2017
- Recall Number
- Z-1455-2015
- Quantity
- 25 units
- Firm Location
- Edison, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution to CA, KY, IL, LA, PA, NC, TN, WV, and Puerto Rico.
Lot / Code Info
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
Root Cause
Packaging process control
Action Taken
MTF notified their customers on 12/4/2014 and 12/8/2014 via phone and letter.