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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77309

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

Open FDA event record

Event summary

Timeline bucket
May 23, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
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

3 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 3

ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E

Z-2646-2017
Recall number
Z-2646-2017
Initiated
May 23, 2017
Classification
Class II
Status
Terminated
Recalling firm
Onkos Surgical, Inc.
Quantity
4 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrectly labeled

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

The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm

Code information

LOT 1700558

Distribution pattern

AZ, IL & KS

device · product 2 of 3

ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E

Z-2647-2017
Recall number
Z-2647-2017
Initiated
May 23, 2017
Classification
Class II
Status
Terminated
Recalling firm
Onkos Surgical, Inc.
Quantity
4 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrectly labeled

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

The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm

Code information

LOT 1700559

Distribution pattern

AZ, IL & KS

device · product 3 of 3

ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E

Z-2648-2017
Recall number
Z-2648-2017
Initiated
May 23, 2017
Classification
Class II
Status
Terminated
Recalling firm
Onkos Surgical, Inc.
Quantity
4 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrectly labeled

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

The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm

Code information

LOT 1699599

Distribution pattern

AZ, IL & KS