Reported Jun 4, 2025 · Ongoing

a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem,…

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?

a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH
Model Numbers
- CS-09100-03M
- CS-10100-03M. b. Segmental Stem
- Cemented
- Straight
- 120MM
- 1 EACH
Model NumbersCS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM

Lot codes and dates: 12 of 12 products
Products covered by this recall
Model / number Product as published
CS-09100-03M UDI-DI: B278CS0910003M0
— Lot Numbers: 1880308, 1880309, 1880310, 1880311, 1880312, 1880313, 1880314, 1880315, 1880316, 1880317, 1880318, 1880319, 1880320, 1880321, 1880322, 1880323, 1880324, 1880325, 1880326, 1880327, 1880328, 1880329, 1880330, 1880331, 1880332, 1880333.
CS-10100-03M. UDI-DI: B278CS1010003M0.
— Lot Numbers: 1880334, 1880335, 1880336, 1880337, 1880338, 1880339, 1880340, 1880341, 1880342, 1880343, 1880344, 1880345. b.
CS-11120-03M UDI-DI: B278CS1112003M0
— Lot Numbers: 1880346, 1880347, 1880348, 1880349, 1880350, 1880351, 1880352, 1880353, 1880354, 1880355, 1880356, 1880357, 1880358, 1880359, 1880360, 1880361, 1880362, 1880363, 1880364, 1880365, 1880366, 1880367, 1880368, 1880369, 1880370, 1880371, 1880372, 1880373, 1880374, 1880375, 1880376.
CS-13120-03M UDI-DI: B278CS1312003M0
— Lot Numbers: 1880377, 1880378, 1880379, 1880380, 1880381, 1880382, 1880383, 1880384, 1880385, 1880386, 1880387, 1880388, 1880389, 1880390, 1880391, 1880392, 1880393, 1880394, 1880395, 1880396, 1880397, 1880398, 1880399, 1880400, 1880401, 1880402, 1880403, 1880404, 1880405, 1880406, 1880407, 1880408, 1880409.
CS-15120-03M UDI-DI: B278CS1512003M0
— Lot Numbers: 1880410, 1880411, 1880412, 1880413, 1880414, 1880415, 1880416, 1880417, 1880418, 1880419, 1880420, 1880421, 1880422, 1880423, 1880424, 1880425.
CS-17120-03M UDI-DI: B278CS1712003M0
— Lot Numbers: 1880426, 1880427, 1880428, 1880429, 1880430, 1880431, 1880432, 1880433, 1880434, 1880435, 1880436, 1880437, 1880438, 1880439, 1880440, 1880441, 1880442, 1880443, 1880444, 1880445, 1880446, 1880447, 1880448, 1880449, 1880450, 1880451, 1880452, 1880453, 1880454.
Amount recalled: 147 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.

Want the full recall guide?

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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Model / number	Product as published
`CS-09100-03M`	UDI-DI: B278CS0910003M0
—	Lot Numbers: 1880308, 1880309, 1880310, 1880311, 1880312, 1880313, 1880314, 1880315, 1880316, 1880317, 1880318, 1880319, 1880320, 1880321, 1880322, 1880323, 1880324, 1880325, 1880326, 1880327, 1880328, 1880329, 1880330, 1880331, 1880332, 1880333.
`CS-10100-03M.`	UDI-DI: B278CS1010003M0.
—	Lot Numbers: 1880334, 1880335, 1880336, 1880337, 1880338, 1880339, 1880340, 1880341, 1880342, 1880343, 1880344, 1880345. b.
`CS-11120-03M`	UDI-DI: B278CS1112003M0
—	Lot Numbers: 1880346, 1880347, 1880348, 1880349, 1880350, 1880351, 1880352, 1880353, 1880354, 1880355, 1880356, 1880357, 1880358, 1880359, 1880360, 1880361, 1880362, 1880363, 1880364, 1880365, 1880366, 1880367, 1880368, 1880369, 1880370, 1880371, 1880372, 1880373, 1880374, 1880375, 1880376.
`CS-13120-03M`	UDI-DI: B278CS1312003M0
—	Lot Numbers: 1880377, 1880378, 1880379, 1880380, 1880381, 1880382, 1880383, 1880384, 1880385, 1880386, 1880387, 1880388, 1880389, 1880390, 1880391, 1880392, 1880393, 1880394, 1880395, 1880396, 1880397, 1880398, 1880399, 1880400, 1880401, 1880402, 1880403, 1880404, 1880405, 1880406, 1880407, 1880408, 1880409.
`CS-15120-03M`	UDI-DI: B278CS1512003M0
—	Lot Numbers: 1880410, 1880411, 1880412, 1880413, 1880414, 1880415, 1880416, 1880417, 1880418, 1880419, 1880420, 1880421, 1880422, 1880423, 1880424, 1880425.
`CS-17120-03M`	UDI-DI: B278CS1712003M0
—	Lot Numbers: 1880426, 1880427, 1880428, 1880429, 1880430, 1880431, 1880432, 1880433, 1880434, 1880435, 1880436, 1880437, 1880438, 1880439, 1880440, 1880441, 1880442, 1880443, 1880444, 1880445, 1880446, 1880447, 1880448, 1880449, 1880450, 1880451, 1880452, 1880453, 1880454.

Is this the product you have?

This recall covers 9 products

Where it was sold

Why it was recalled

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