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Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model… recallZ-1882-2025 · Onkos Surgical, Inc. · initiated Sep 1, 2023

Class II Open, Classified All recalls posted in May 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Onkos Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for breach of Tyvek seals.

FDA root cause category: Packaging change control

What the company is doing

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.

Recall details

Recall number
Z-1882-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Sep 1, 2023
Posted by the FDA
May 29, 2025
Recalling firm
Onkos Surgical, Inc.
Quantity
77 units
Product code
KRO
FDA submissions
K161520
Distribution
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.

Product description

Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

a. Model Number: FB-11152-03M; UDI-DI: B278FB1115203M0; Lot Numbers: 1880455, 1880456, 1880457, 1880458, 1880459, 1880460, 1880461, 1880462, 1880463. b. Model Number: FB-12152-03M; UDI-DI: B278FB1215203M0; Lot Numbers: 1880464, 1880465, 1880466, 1880467, 1880468, 1880469. c. Model Number: FB-13152-03M; UDI-DI: B278FB1315203M0; Lot Numbers: 1880470, 1880471, 1880472, 1880473. d. Model Number: FB-14152-03M; UDI-DI: B278FB1415203M0; Lot Numbers: 1880474, 1880475, 1880476. e. Model Number: FB-15152-03M; UDI-DI: B278FB1515203M0; Lot Numbers: 1880477, 1880478, 1880479. f. Model Number: FB-16152-03M; UDI-DI: B278FB1615203M0; Lot Numbers: 1880480, 1880481, 1880482, 1880483, 1880484, 1880485, 1880486, 1880487, 1880488. g. Model Number: FB-17152-03M; UDI-DI: B278FB1715203M0; Lot Numbers: 1880489, 1880490, 1880491, 1880492, 1880493, 1880494, 1880495, 1880496, 1880497. h. Model Number: FB-18152-03M; UDI-DI: B278FB1815203M0; Lot Numbers: 1880498, 1880499, 1880500, 1880501, 1880502, 1880503, 1880504, 1880505. i. Model Number: FB-19152-03M; UDI-DI: B278FB1915203M0; Lot Numbers: 1880506, 1880507, 1880508, 1880509, 1880510, 1880511. j. Model Number: FB-20152-03M; UDI-DI: B278FB2015203M0; Lot Numbers: 1880512, 1880513, 1880514, 1880515, 1880516, 1880517, 1880518. k. Model Number: FB-21152-03M; UDI-DI: B278FB2115203M0; Lot Numbers: 1880519, 1880520, 1880521, 1880522, 1880523, 1880524, 1880525, 1880526, 1880527, 1880528, 1880529, 1880530, 1880531.

Other devices under the same FDA submission

157 devices cleared under K161520 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96782).

Sources and updates

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