CLASS II Device recall · Reported 29 Apr 2015 · FDA Enforcement Report

DBX Mix, 20 cc, Product recalled by Musculoskeletal Transplant

Musculoskeletal Transplant Foundation is recalling DBX Mix, 20 cc, distributed nationwide in the US. The recall was initiated on 4 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes064130067910690008; 064130067910690009; 064130067910690004; 064130067910690023; 064130067910690024 064130067910690005; 064130067910690015; 064130067910690016; 064130067910690018; 064130067910690020; 064130067910690007; 064130067910690013; 064130067910690028; 064130067910690029; 064130067910690030; 064130067910690010; 064130067910690006; 064130067910690011; 064130067910690012; 064130067910690019; 064130067910690021; 064130067910690014; 064130067910690017; 064130067910690001; 064130067910690022

Quantity recalled25 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1455-2015
FDA event ID: 70739
Recalling firm: Musculoskeletal Transplant Foundation, Edison, NJ
Classification: Class II
Status: Terminated
Recall initiated: 4 Dec 2014
FDA classified: 17 Apr 2015
Reported: 29 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

4 Dec 2014	Recall initiated by company
17 Apr 2015	Classified by FDA	+134 days
29 Apr 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide California Illinois Kentucky Louisiana North Carolina Pennsylvania Puerto Rico Tennessee West Virginia

Questions about this recall

Why was it recalled?

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

Which lots 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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Musculoskeletal Transplant Foundation

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21 Feb 2024Device	CLASS II	AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product recalled	Musculoskeletal Transplant Foundation	Other	MN
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2 Oct 2019Device	CLASS II	QuickGraft¿ Model # 430PST recalled by Musculoskeletal Transplant	Musculoskeletal Transplant Foundation	Other	5 states

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