Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Grafton DBM Crunch

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Grafton DBM Crunch see related information
Date Initiated by Firm April 20, 2012
Date Posted October 18, 2012
Recall Status1 Terminated 3 on January 17, 2014
Recall Number Z-0087-2013
Recall Event ID 62569
510(K)Number K042707  K043048  K051188  K051195  
Product Classification Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
Product Grafton DBM Crunch
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 Multiple Lots - please see attachment
Recalling Firm/
Manufacturer		 Osteotech Inc
51 James Way
Eatontown NJ 07724-2272
For Additional Information Contact Mr. Eric Epperson
901-344-1435
Manufacturer 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.
FDA Determined
Cause 2		 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.
Quantity in Commerce 3,541 units
Distribution Worldwide Distribution - USA (nationwide) and Internationally.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MBP and Original Applicant = OSTEOTECH, INC.
-
-