Grafton DBM Orthoblend Large Defect Multiple recall: Sterility Concern
Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with…
Why was Grafton DBM Orthoblend Large Defect Multiple 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Multiple Lots - please see attachment
- Product
- Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with…
- Recalling firm
- Osteotech Inc
- Quantity
- 1,274 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally.
- Recall date
- October 24, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)