Z-1868-2014Class II

Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160

Name: Z-1868-2014 Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160
Creator: Integra LifeSciences Corp.
Published: 2014-05-19
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2014-05-19 / Terminated / root cause: packaging

FDA source

Integra LifeSciences Corp. began a recall of Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is... on 2014-05-19. FDA classified it as Class II and gives the reason 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1868-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-19
Posted: 2014-06-25
Terminated: 2014-09-05
Recalling firm: Integra LifeSciences Corporation
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 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.
Product code: MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: Integra sent an Urgent Voluntary Medical Device Recall dated May 19, 2014 to customers via mail (traceable courier service). The recall notification letter identified affected product, reason for recall and actions to be taken Customers were instructed to complete the "RECALL ACKNOWLEDGEMENT AND RETURN FORM". and return to: [email protected] or FAX to 1-609-275-9445. For questions contact Customer Service at 1-800-550-7155.
Quantity in commerce: 61
Distribution: US Nationwide Distribution
Product codes and lots: Model Number: 02-6000-050 , Lot Number: 132160.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1868-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1868-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24

Product code MBP

K091193Class IIAccell Evo3cIsotis Orthobiologics, Inc. / cleared 2009-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)