Reported Jun 4, 2025 · Ongoing
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M,…
Onkos Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Onkos Surgical, Inc. · 77 E Halsey Rd · Parsippany, NJ · 07054-3714
Is this the product you have?
- Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH
- Model NumbersFB-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
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Product as published FB-11152-03MUDI-DI: B278FB1115203M0; Lot Numbers: 1880455, 1880456, 1880457, 1880458, 1880459, 1880460, 1880461, 1880462, 1880463. FB-12152-03MUDI-DI: B278FB1215203M0; Lot Numbers: 1880464, 1880465, 1880466, 1880467, 1880468, 1880469. FB-13152-03MUDI-DI: B278FB1315203M0; Lot Numbers: 1880470, 1880471, 1880472, 1880473. FB-14152-03MUDI-DI: B278FB1415203M0; Lot Numbers: 1880474, 1880475, 1880476. FB-15152-03MUDI-DI: B278FB1515203M0; Lot Numbers: 1880477, 1880478, 1880479. FB-16152-03MUDI-DI: B278FB1615203M0; Lot Numbers: 1880480, 1880481, 1880482, 1880483, 1880484, 1880485, 1880486, 1880487, 1880488. FB-17152-03MUDI-DI: B278FB1715203M0; Lot Numbers: 1880489, 1880490, 1880491, 1880492, 1880493, 1880494, 1880495, 1880496, 1880497. FB-18152-03MUDI-DI: B278FB1815203M0; Lot Numbers: 1880498, 1880499, 1880500, 1880501, 1880502, 1880503, 1880504, 1880505. FB-19152-03MUDI-DI: B278FB1915203M0; Lot Numbers: 1880506, 1880507, 1880508, 1880509, 1880510, 1880511. FB-20152-03MUDI-DI: B278FB2015203M0; Lot Numbers: 1880512, 1880513, 1880514, 1880515, 1880516, 1880517, 1880518. FB-21152-03MUDI-DI: B278FB2115203M0; Lot Numbers: 1880519, 1880520, 1880521, 1880522, 1880523, 1880524, 1880525, 1880526, 1880527, 1880528, 1880529, 1880530, 1880531. - Amount recalled
- 77 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
Potential for breach of Tyvek seals.
This product could cause temporary or reversible health problems — stop using it.
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