Regulatory Record: Orthorebirth Co Ltd

FDA action counts

Enforcement history

On 2026-05-13, Argus HQ recorded a FDA recall for Orthorebirth Co Ltd, rated "high" severity in Argus HQ's classification: Orthorebirth Co Ltd — Class II recall: ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Orthorebirth Co Ltd, rated "high" severity in Argus HQ's classification: Orthorebirth Co Ltd — Class II recall: BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC,… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Orthorebirth Co Ltd has 2 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Counting an FDA record here does not by itself indicate an unresolved problem -- warning letters, recalls, and inspection observations are frequently closed out once a firm completes FDA-required corrective action.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Orthorebirth Co Ltd has 2 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.

Frequently asked questions

Is this FDA enforcement data for Orthorebirth Co Ltd official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Orthorebirth Co Ltd had?

Argus HQ has recorded 2 FDA events for Orthorebirth Co Ltd: 0 warning letters, 2 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Orthorebirth Co Ltd?

The most recent FDA event Argus HQ has on file for Orthorebirth Co Ltd is dated 2026-05-13, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for Orthorebirth Co Ltd automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Orthorebirth Co Ltd is observed, this page's event count and history update automatically.

Related enforcement actions

• Orthorebirth Co Ltd — Class II recall: ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z →
• Orthorebirth Co Ltd — Class II recall: BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC,… →

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