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Grafton DBM A-Flex recallZ-0086-2013 · Osteotech Inc · initiated Apr 20, 2012

Class II Terminated All recalls posted in October 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Osteotech Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0086-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 20, 2012
Posted by the FDA
Oct 18, 2012
Recalling firm
Osteotech Inc
Quantity
215 units
Product code
MBP
FDA submissions
K042707, K043048, K051188, K051195
Distribution
Worldwide Distribution - USA (nationwide) and Internationally.

Product description

Grafton DBM A-Flex Multiple Sizes 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.

Code information (models, lots, serial numbers)

Multiple Lots - please see attachment

Other devices under the same FDA submission

38 devices cleared under K042707, K043048, K051188, K051195 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 62569).

Sources and updates

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