GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T45005Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 3 still open.

12 other recalls cover devices cleared under the same FDA submission (K042707, K043048); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 12, 2026Open, Classified

   Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection

   Z-0137-2027 · Root cause: Process change control · Recall details · FDA record ↗

2. Sep 26, 2023Class IIOpen, Classified

   Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

   Z-0166-2024 · Root cause: Employee error · Recall details · FDA record ↗

3. Feb 8, 2023Class IIOpen, Classified

   Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

   Z-1329-2023 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042707, K043048. One submission often covers many models, so check the product and lot details in each record.

• Z-0094-2013 · Apr 20, 2012 · Terminated
  Optimum Expanse S Multiple sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone ma
• Z-0085-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone mat
• Z-0091-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a de
• Z-0087-2013 · Apr 20, 2012 · Terminated
  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 m
• Z-0086-2013 · Apr 20, 2012 · Terminated
  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 m
• Z-0093-2013 · Apr 20, 2012 · Terminated
  Optimum Expanse R Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allo
• Z-0084-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matr
• Z-0090-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a dem
• Z-0089-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized
• Z-0088-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bo
• Z-0092-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a de
• Z-0083-2013 · Apr 20, 2012 · Terminated
  Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone ma