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.
What this means for you
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
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