FDA Medical Device Recalls (openFDA)
Musculoskeletal Transplant Foundation, Inc.: DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
- Recall number
- Z-1455-2015
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc.
- Product
- DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
- Status
- Terminated
- Initiated
- 2014-12-04
- Posted
- 2015-04-17
- Terminated
- 2017-05-08
- Reason
- The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact.
- Root cause
- Packaging process control
- Action
- MTF notified their customers on 12/4/2014 and 12/8/2014 via phone and letter.
- Quantity
- 25 units
- Distribution
- US Nationwide distribution to CA, KY, IL, LA, PA, NC, TN, WV, and Puerto Rico.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K040262"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3001236616
- Firm city
- Edison
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28