Z-0093-2013Class II

Optimum Expanse R Grafton is a human bone allograft product containing demineralized human bone tissue...

Name: Z-0093-2013 Optimum Expanse R Grafton is a human bone allograft product containing demineralized human bone tissue...
Creator: Osteotech Inc
Published: 2012-04-20
License: https://open.fda.gov/license/

Osteotech Inc / initiated 2012-04-20 / Terminated / root cause: design

FDA source

Osteotech Inc began a recall of Optimum Expanse R Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized... on 2012-04-20. FDA classified it as Class II and gives the reason as "Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0093-2013
Classification: Class II
Status: Terminated
Initiated: 2012-04-20
Posted: 2012-10-18
Terminated: 2014-01-17
Recalling firm: Osteotech Inc
Product: Optimum Expanse R Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone.
Product code: MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Reason for recall: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
Root cause tag: design
FDA root cause: Device Design
Action: Osteotech sent out recall letters/questionairres dated April 20, 2012, to Risk Managers/service representatives. The recall was expanded on August 1 2012. The letter identified the product, the problem, and the action to be taken by the customer. Sales Representatives would facillitate the return of any affected product they may have or provide cautionary labels for any affected product and/or support in the completion of the attached questionnaire. Customers were asked to disseminate this information to additional personnel within their facility as appropriate and return the questionnaire to Medtronic.. Customers with questions should contact their Medtronic Sales Representative at 800-876-3133, extension 3197. For questions regarding this recall call 732-542-2800. Osteotech sent an additional letter stating that The OPTIUMTM (DBM) product line was added in error.
Distribution: Worldwide Distribution - USA (nationwide) and Internationally.
Product codes and lots: Multiple Lots - please see attachment

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0093-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0083-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18
Z-0084-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18
Z-0085-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18
Z-0086-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18
Z-0087-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18
Z-0088-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18
Z-0089-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18
Z-0090-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18
Z-0091-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18
Z-0092-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18
Z-0093-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18
Z-0094-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18

Product code MBP

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)