ZENBONE Bone Void Filler Recall
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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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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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 ↗
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