ZENBONE Bone Void Filler Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Orthorebirth Co Ltd is recalling 20 units of ZENBONE resorbable bone void fillers distributed in CA and FL because the products fall outside standard specifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 26, 2026 and geographically references California, Florida. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Orthorebirth Co Ltd initiated a voluntary recall of ZENBONE resorbable bone void fillers after determining the products fall outside standard specifications.
Which Products Are Affected
- Product: ZENBONE
- References: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
- UDI-DI: 04573190050637
- Lots: 25F07104JF, 25F07105JF, 25F07106JF
- Quantity: 20 units
- Distribution: US Nationwide in CA and FL
- Recall Number: Z-2132-2026
- Classification: Class II
What You Should Do
Consumers in possession of the affected products should contact the recalling firm for return or further instructions.
Why This Matters
This Class II recall involves a medical device that may cause temporary or reversible adverse health consequences.
Source
FDA recall Z-2132-2026 (report date 20260513)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (800 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.