ZENBONE Bone Void Filler Recall

Source: FDA · California, Florida

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 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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, medical-devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects California, Florida. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.