Integra Recalls Accell Evo3C Bone Matrix Due to Packaging Error
Integra LifeSciences is recalling 61 units of Accell Evo3C Demineralized Bone Matrix because they were incorrectly packaged in boxes for a different product, creating a risk of improper surgical use.
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, which typically corresponds to a moderate severity score. The hazard involves a labeling/packaging error that could lead to the use of a contraindicated product, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Integra LifeSciences Corp. is recalling 61 units of Accell Evo3C Demineralized Bone Matrix, 5 cc (Model Number: 02-6000-050, Lot Number: 132160). The product was distributed nationwide in the United States.
The recall was initiated because the specific lot was incorrectly packaged in boxes that describe the product as "Accell Evo Demineralized Bone Matrix" rather than "Accell Evo3C." This packaging error creates a risk that the product may be used inappropriately, as Evo3C is contraindicated for the treatment of vertebral compression and is not indicated for use in the posterolateral spine.
Healthcare providers and patients who have received this specific lot should stop using the product and contact Integra LifeSciences Corp. for instructions on return or replacement.
The recalled product
- Product
- Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the…
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Bone Graft
- Affected units
- 61
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 (2)
- Model Number: 02-6000-050
- Lot Number: 132160.
Distribution
Distributed nationwide across the United States.
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