Filler, Bone Void, Calcium Compound

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

• 2026-07-28Open, ClassifiedProcess control

  OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095

  Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.

• 2026-05-07Open, ClassifiedDevice Design

  BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC

  Resorbable bone void filler falls outside standard specifications.

• 2026-05-07Open, ClassifiedDevice Design

  ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

  Resorbable bone void filler falls outside standard specifications.

• 2026-04-21Open, ClassifiedIncorrect or no expiration date

  nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc

  Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

• 2025-11-18Open, ClassifiedProcess control

  Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure.

  Due to incorrect product label (Incorrect product name identified on outer packaging).

• 2025-05-02Open, ClassifiedProcess control

  Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

  Vials of implant bone granules may contain less product then specified on labeling.

• 2025-01-16Open, ClassifiedLabeling Change Control

  OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.

  Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.

• 2025-01-15Open, ClassifiedUnder Investigation by firm

  OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

  Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.

• 2024-02-09Open, ClassifiedNonconforming Material/Component

  AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)

  Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.

• 2024-02-09Open, ClassifiedNonconforming Material/Component

  AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)

  Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.