Exact FDA event identifier

Event 98733

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 25, 2026
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Orthorebirth Co Ltd

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC

Z-2131-2026

Recall number: Z-2131-2026
Initiated: March 25, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Orthorebirth Co Ltd
Quantity: 1266

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Resorbable bone void filler falls outside standard specifications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Resorbable bone void filler falls outside standard specifications.

Code information

UDI-DI: 04573190050552. Lots: 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, 25H27101AA

Distribution pattern

US Nationwide distribution in the states of CA, FL.

device · product 2 of 2

ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

Z-2132-2026

Recall number: Z-2132-2026
Initiated: March 25, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Orthorebirth Co Ltd
Quantity: 20

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Resorbable bone void filler falls outside standard specifications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Resorbable bone void filler falls outside standard specifications.

Code information

UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF

Distribution pattern

US Nationwide distribution in the states of CA, FL.