Z-1455-2015 Class II Terminated
FDA device recall Z-1455-2015 was initiated by Musculoskeletal Transplant Foundation, Inc. on December 4, 2014 and is designated Class II. 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. The recall status is terminated (terminated May 8, 2017). Affected quantity: 25 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2015
- Initiation Date
- December 4, 2014
- Termination Date
- May 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 units
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.
Distribution Pattern
US Nationwide distribution to CA, KY, IL, LA, PA, NC, TN, WV, and Puerto Rico.
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