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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97601

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 02, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Berkeley Advanced Biomaterials, LLC

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

1 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 1

Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure.

Z-0540-2026
Recall number
Z-0540-2026
Initiated
September 02, 2025
Classification
Class II
Status
Ongoing
Quantity
62 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label (Incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to incorrect product label (Incorrect product name identified on outer packaging).

Code information

Catalog Number: M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Lot Number: EBL10B13C Serial Numbers: EBL10112 - EBL10115 EBL10051-EBL10053, EBL10055-EBL10058 EBL10064 - EBL10073 EBL10075 - EBL10109

Distribution pattern

U.S. Nationwide distribution in the state of TN.