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Open, Classified

Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM

FDA Recall Z-1881-2025 · Posted 2025-05-29

Recalling FirmOnkos Surgical, Inc.
Recall StatusOpen, Classified
Product CodeKRO
Date Initiated2023-09-01
Product Quantity120 units

Reason for Recall

Potential for breach of Tyvek seals.

Firm Action

Onkos Surgical began notifying consignees on about 09/01/2023 via email. Consignees were instructed to complete and return the response form providing the affected lot numbers being returned, coordinate the return of affected units, and to note that when placing these parts into totes, always place them flat.

Root Cause

Packaging change control

Distribution Pattern

Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc. · 2016-10-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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