ZENBONE Resorbable Bone Void Filler Recall Outside Specifications
Orthorebirth Co Ltd is recalling ZENBONE resorbable bone void filler because the product falls outside standard specifications. The recall affects specific lot numbers distributed nationwide in California and Florida.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source does not report any illnesses, injuries, or hospitalization; the hazard is that the product falls outside specifications, making this a moderate-severity precautionary recall without known adverse health events.
Plain-English summary
Orthorebirth Co Ltd is recalling ZENBONE resorbable bone void filler (Reference numbers ORB-0320C-Z, ORB-0310C-Z, and ORB-0304C-Z) because the product falls outside standard specifications.
The affected lots are 25F07104JF, 25F07105JF, and 25F07106JF. The product has been distributed nationwide in California and Florida.
Patients who have received this product should contact their healthcare provider or Orthorebirth Co Ltd for further guidance. Healthcare providers should discontinue use of affected lots and consult the manufacturer regarding appropriate patient management.
The recalled product
- Product
- ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
- Manufacturer
- Orthorebirth Co Ltd
- Hazard
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 04573190050637. Lots: 25F07104JF
- 25F07105JF
- 25F07106JF
Distribution
Part of a larger recall action
This product is one of 2 recalled by Orthorebirth Co Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Orthorebirth Co Ltd
See all →- HighBioCera Fibers Bioresorbable Bone Void Filler Recall
FDA (Devices) · 2026-05-13
Same hazard · specification defect
See all →- LowCVS Lidocaine Wound Gel recalled for failed pH specifications
FDA (Drugs) · 2026-05-06
- HighStryker Precision Thin surgical blade attachments recalled for specification defect
FDA (Devices) · 2025-02-19
- HighCryo Module Tank Hose Assemblies Recalled for Material and Design Defects
FDA (Devices) · 2024-02-07
- ModerateEVO VISIAN Intraocular Lens Recalled Due to Specification Concerns
FDA (Devices) · 2023-12-13
- HighKWIK-STIK Quality Control Kit Recalled for Incorrect Antibiotic Susceptibility
FDA (Devices) · 2022-03-09
Similar recalls
- ModerateSynthes Recalls 22 Rapid Resorbable Orbital Floor Plates Due to Labeling Errors
FDA (Devices) · 2016-06-15
- ModerateOsteomed Recalls Osteovation RMX Injectable Bone Void Filler Kits
FDA (Devices) · 2020-06-10
- ModerateSynthes Rapid Resorbable Orbital Floor Plate Recalled for Labeling Errors
FDA (Devices) · 2016-06-15
- ModerateOsteomed Recalls Osteovation RMX Injectable Due to Shelf-Life Labeling Error
FDA (Devices) · 2020-06-10
- HighVivorte Bone Void Filler Recalled for Incorrect Expiration Date
FDA (Devices) · 2021-07-14
- ModerateSynthes Recalls 1.5 mm Rapid Resorbable Orbital Floor Plates Due to Labeling Errors
FDA (Devices) · 2016-06-15