Class IIOngoingZ-2132-2026
Orthorebirth Co Ltd recalls ZENBONE
Resorbable bone void filler falls outside standard specifications.
- Calcium Compound Bone Void Filler
- Device Design
Orthorebirth Co LtdMay 13, 2026
Calcium Compound Bone Void Filler recalls
The FDA has posted 7 enforcement recalls of calcium compound bone void filler devices since 2025, none of them Class I (most serious). Most recent report: May 13, 2026.
Class II: 7
Who is recalling these devices
Latest recalls
View all 7 in the recall browser →Class IIOngoingZ-2131-2026
Orthorebirth Co Ltd recalls BioCera Fibers
Resorbable bone void filler falls outside standard specifications.
- Calcium Compound Bone Void Filler
- Device Design
Orthorebirth Co LtdMay 13, 2026
Class IIOngoingZ-1897-2026
XTANT Medical Holdings, Inc recalls nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute…
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
- Calcium Compound Bone Void Filler
- Incorrect or no expiration date
XTANT Medical Holdings…MTApr 29, 2026
Class IIOngoingZ-0540-2026
Berkeley Advanced Biomaterials, LLC recalls Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(…
Due to incorrect product label (Incorrect product name identified on outer packaging).
- Calcium Compound Bone Void Filler
- Process control
Berkeley Advanced Biom…CANov 26, 2025
Class IIOngoingZ-1718-2025
SCIENCE & BIO MATERIALS recalls Bio 1 Granules for Filling ¿ 1 mm (2 cm¿)
Vials of implant bone granules may contain less product then specified on labeling.
- Calcium Compound Bone Void Filler
- Process control
SCIENCE & BIO MATERIAL…May 14, 2025
Class IIOngoingZ-0955-2025
IsoTis OrthoBiologics, Inc. recalls OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
- Calcium Compound Bone Void Filler
- Labeling Change Control
IsoTis OrthoBiologics,…CAJan 22, 2025
Class IIOngoingZ-0919-2025
IsoTis OrthoBiologics, Inc. recalls OsteoCove Putty
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
- Calcium Compound Bone Void Filler
- Under Investigation by firm
IsoTis OrthoBiologics,…CAJan 22, 2025
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Filler, Bone Void, Calcium Compound”). Informational only — verify against the FDA before acting.