CLASS II Device recall · Reported 24 Oct 2012 · FDA Enforcement Report
Grafton DBM Crunch Multiple Sizes Grafton is a human bone recalled
Osteotech is recalling Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing, distributed nationwide in the US. The recall was initiated on 20 Apr 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0087-2013
- FDA event ID
- 62569
- Recalling firm
- Osteotech, Eatontown, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Apr 2012
- FDA classified
- 18 Oct 2012
- Reported
- 24 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Spinal Implants
Timeline
| 20 Apr 2012 | Recall initiated by company | |
| 18 Oct 2012 | Classified by FDA | +181 days |
| 24 Oct 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally.
Questions about this recall
Is Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing recalled?
Yes. Osteotech recalled Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing on 20 Apr 2012. The recall is Class II and its status is Terminated. Recall number Z-0087-2013.
Why was it 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.
Which lots are affected?
Multiple Lots - please see attachment
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
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| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
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