Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Accell Evo3C Demineralized Bone Matrix Recalled by Integra LifeSciences Corp. Due to This lot of Accell Evo3C Demineralized Bone Matrix,...

Date: May 19, 2014
Company: Integra LifeSciences Corp.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.

Affected Products

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 bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Quantity: 61

Why Was This Recalled?

This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix. Evo3C is contraindicated for treatment of vertebral compression and not indicated for use in the posterolateral spine.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Integra LifeSciences Corp.

Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report