Recall events
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Event 97343
Event summary
Timeline bucket July 11, 2025
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
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 SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Z-2423-2025
Recall number Z-2423-2025
Initiated July 11, 2025
Classification Class II
Status Ongoing
Quantity 30 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2423-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23298]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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Inspect official wording and provenance
Reason for recall Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Code information Model No. 2500BP20E, 2500BP22E; UDI: B2782500BP20E0, B2782500BP22E0; Lot No. All lots released prior to 2025-07-11.
Distribution pattern US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[2367]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
Z-2424-2025
Recall number Z-2424-2025
Initiated July 11, 2025
Classification Class II
Status Ongoing
Quantity 15 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2424-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17228]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Code information Model No. 2500CP16E; UDI: B2782500CP16E0; Lot No. All lots released prior to 2025-07-11.
Distribution pattern US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[2597]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Z-2425-2025
Recall number Z-2425-2025
Initiated July 11, 2025
Classification Class II
Status Ongoing
Quantity 554 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2425-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40906]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Code information Model No. KSP17100E, KSP17140E, KSP18100E, KSP18140E, KSP20100E, KSP20140E, KSP22100E; UDI: B278KSP17100E0, B278KSP17140E0, B278KSP18100E0, B278KSP18140E0, B278KSP20100E0, B278KSP20140E0, B278KSP22100E0; Lot No. All lots released prior to 2025-07-11.
Distribution pattern US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[2614]
FDA event record
· Exact recall-number query on openFDA
