GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44115Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169123113), received between Jul 7, 2025 and Jul 7, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).

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

28 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. 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-0161-2024 · Root cause: Employee error · Recall details · FDA record ↗

2. 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-1324-2023 · Root cause: Process control · Recall details · 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.

• MalfunctionJul 7, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  INFORMATION RECEIVED FROM USER FACILITY VIA A MANUFACTURING REPRESENTATIVE REGARDING A PART USED FOR SPINAL THERAPY. IT WAS REPORTED THAT SEAL WAS BROKEN PRIOR TO OPENING PRODUCT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410147 ↗

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-0138-2027 · Aug 12, 2026 · Open, Classified
  Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a par
• Z-0166-2024 · Sep 26, 2023 · Open, Classified
  Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
• Z-0163-2024 · Sep 26, 2023 · Open, Classified
  Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
• Z-0162-2024 · Sep 26, 2023 · Open, Classified
  Grafton DBM (Flex), Model Numbers: T42100, 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-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-0164-2024 · Sep 26, 2023 · Open, Classified
  Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix
• 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-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-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-1328-2023 · Feb 8, 2023 · Open, Classified
  Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 E
• 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-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-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

…and 13 more.