Exact FDA event identifier

Event 96780

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

Open FDA event record

Event summary

Timeline bucket: September 22, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Onkos Surgical, Inc.

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

ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

Z-1857-2025

Recall number: Z-1857-2025
Initiated: September 22, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Onkos Surgical, Inc.
Quantity: 24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

Code information

Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874

Distribution pattern

US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.