Food, drugs, devices › Integra LifeSciences Corp.
Device recall: Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3
FDA enforcement event 68330 is a device recall by Integra LifeSciences Corp. of Plainsboro, NJ, initiated 19 May 2014 and classified Class II, with 1 product record.
FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 5 Sep 2014. Initiation: voluntary: firm initiated. Integra LifeSciences Corp. has 79 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Integra LifeSciences Corp., Plainsboro, NJ.
Reason for recall
"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."
Distribution
"US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1868-2014 | 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… | 61 | Class II | Terminated | 2 Jul 2014 |
Context
Other enforcement events for Integra LifeSciences Corp.
All 79 events for Integra LifeSciences Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Sep 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.