GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42275Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169123076), received between Sep 5, 2025 and Sep 5, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

27 other recalls cover devices cleared under the same FDA submission (K051195); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 26, 2023Open, 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-0164-2024 · Root cause: Employee error · FDA record ↗

2. Feb 8, 2023Open, 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-1328-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Off-Label Use; Off-Label Use

  INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE FROM PATIENT WHO WAS IMPLANTED WITH GRAFTON. IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH REPORTED GRAFTON DURING CERVICAL SPINE SURGERY ON (B)(6) 2020. DURING THIS SURGERY, THE GRAFTON BONE GRAFT PRODUCT WAS IMPLANTED IN PATIENT'S CERVICAL SPINE. PATIENT ALLEGED THAT USING GRAFTON IN THE CERVICAL SPINE WAS A DANGEROUS "OFF-LABEL" USE. FOLLOWING THE SURGERY AND IMPLANTATION OF GRAFTON, PATIENT SUFFERED SEVERE AND DEBILITATING INJURIES, INCLUDING BUT NOT LIMITED TO, UNCONTROLLED ECTOPIC BONE GROWTH, NERVE DAMAGE, NEED FOR ADDITIONAL SURGERIES, DAILY DEBILITATING NERVE PAIN, DECREASE IN MOBILITY AND MOVEMENTS OF THE NECK.

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Nerve Damage; Pain

  MAUDE report 22977055 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051195. One submission often covers many models, so check the product and lot details in each record.

• Z-0166-2024 · Sep 26, 2023 · Open, Classified
  Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
• Z-0165-2024 · Sep 26, 2023 · Open, Classified
  Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
• Z-0163-2024 · Sep 26, 2023 · Open, Classified
  Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
• Z-0161-2024 · Sep 26, 2023 · Open, Classified
  Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
• Z-0167-2024 · Sep 26, 2023 · Open, Classified
  Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
• Z-0162-2024 · Sep 26, 2023 · Open, Classified
  Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
• Z-1324-2023 · Feb 8, 2023 · Open, Classified
  Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T4410
• Z-1326-2023 · Feb 8, 2023 · Open, Classified
  Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DE
• Z-1333-2023 · Feb 8, 2023 · Open, Classified
  Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT
• Z-1325-2023 · Feb 8, 2023 · Open, Classified
  Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T
• Z-1327-2023 · Feb 8, 2023 · Open, Classified
  Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON
• Z-1323-2023 · Feb 8, 2023 · Open, Classified
  Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S
• Z-0977-2014 · Jan 6, 2014 · Terminated
  Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - f
• 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

…and 12 more.