Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1455-2015·Announced 2015-04-29

DBX Mix Bone Void Filler Recalled for Potential Packaging Seal Defect

Musculoskeletal Transplant Foundation is recalling 25 units of DBX Mix bone void filler because the outer packaging seal may not be fully intact.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a packaging seal defect with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Musculoskeletal Transplant Foundation, Inc. is recalling 25 units of DBX Mix, 20 cc, Product Code: 058200. This product is a demineralized bone matrix mix used as a bone void filler. The recall is being conducted because the seal on the outer PETG/Aclar tray with foil lid packaging may not be fully intact.

The affected units were distributed nationwide to California, Kentucky, Illinois, Louisiana, Pennsylvania, North Carolina, Tennessee, West Virginia, and Puerto Rico. The recall covers specific lot numbers and product codes listed in the official FDA record.

Healthcare providers and patients should stop using the affected DBX Mix units and contact the manufacturer or their supplier for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
Manufacturer: Musculoskeletal Transplant Foundation, Inc.
Category: Medical Device — Bone Graft Material
Hazard: packaging-defect
contamination-risk
Affected units: 25

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

064130067910690008
064130067910690009
064130067910690004
064130067910690023
064130067910690024 064130067910690005
064130067910690015
064130067910690016
064130067910690018
064130067910690020
064130067910690007
064130067910690013
064130067910690028
064130067910690029
064130067910690030
064130067910690010
064130067910690006
064130067910690011
064130067910690012
064130067910690019
064130067910690021

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Same manufacturer · Musculoskeletal Transplant Foundation, Inc.

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