Reported Jun 4, 2025 · Ongoing
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M.…
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, Cemented, Bowed, 152MM, 1 EACH
- Model NumbersCB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published CB-11152-03MUDI-DI: B278CB1115203M0; Lot Numbers: 1880259, 1880260, 1880261, 1880262, 1880263, 1880264, 1880265, 1880266, 1880267, 1880268, 1880269, 1880270, 1880271, 1880272, 1880273, 1880274. CB-13152-03MUDI-DI: B278CB1315203M0; Lot Numbers: 1880275, 1880276, 1880277, 1880278, 1880279, 1880280, 1880281, 1880282, 1880283, 1880284. CB-15152-03MUDI-DI: B278CB1515203M0; Lot Numbers: 1880285, 1880286, 1880287, 1880288, 1880289, 1880290, 1880291, 1880292, 1880293, 1880294, 1880295, 1880296. CB-17152-03MUDI-DI: B278CB1715203M0; Lot Numbers: 1880297, 1880298, 1880299, 1880300, 1880301, 1880302, 1880303, 1880304, 1880305, 1880306, 1880307. - Amount recalled
- 49 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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