BioCera Fibers Bone Void Filler Recall
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Orthorebirth Co Ltd has initiated a voluntary recall of BioCera Fibers Bioresorbable Bone Void Filler distributed in the US due to products falling 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 United States. 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, MedicalDevices.
What Happened
Orthorebirth Co Ltd is recalling BioCera Fibers, a resorbable bone void filler, because the product falls outside standard specifications.
Which Products Are Affected
The recall covers 1,266 units of BioCera Fibers, Bioresorbable Bone Void Filler with REF numbers ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, and ORB-0305D-KC. Affected lots include 25043001, 25043002, 25043003, 25051401, 25051402, 25051701, 25051702, 25060701, 25060702, 25060703, 25060704, 25083001, 25083002, 25083003, 25083004, 25083005, 25120301, 25122701, 25122702, 26020401, 25F07101AA, 25F07103AA, 25F07106AA, 25H27105AA, 25H27107AA, 25H27102AA, 25H27103AA, 25H27104AA, 25K08102AA, 25K08103AA, 25K08101AA, 25J27104AA, 25J27103AA, 25J27102AA, 25J27101AA, 25H27108AA, and 25H27101AA. The recall number is Z-2131-2026. Products were distributed nationwide in CA and FL.
What You Should Do
Consumers and healthcare providers should follow instructions provided by the recalling firm regarding the affected devices.
Why This Matters
The recalled devices are used as bone void fillers and failure to meet specifications may affect their performance in medical procedures.
Source
FDA Recall Z-2131-2026 - Orthorebirth Co Ltd, Yokohama, Japan
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 (1,276 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.