Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue c

FDA device recall Z-0086-2013 · posted 2012-10-18 · Terminated

Recall details

Recalling firm: Osteotech Inc
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.
Action taken: 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.
Root cause: Device Design
Status: Terminated
Product code: MBP
Quantity affected: 215 units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally.
Date initiated: 2012-04-20
Date posted: 2012-10-18
Date terminated: 2014-01-17
Location: Eatontown, NJ

Recalls and clearances share one API, with change alerts when new recalls post.