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RecallWatchMedical Device Safety
Class IIOngoingZ-1879-2025

Onkos Surgical, Inc. recalls a. Segmental Stem

Onkos Surgical, Inc.Parsippany, NJ, United StatesReported Jun 4, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Potential for breach of Tyvek seals.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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 Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM

Lot / code information

Model
CS-09100-03M
UDI
B278CS0910003M0
Lot #
1880308, 1880309, 1880310, 1880311, 1880312, 1880313 — +20 moreShow all
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
Model
CS-10100-03M
UDI
B278CS1010003M0
Lot #
1880334, 1880335, 1880336, 1880337, 1880338, 1880339, 1880340, 1880341, 1880342, 1880343, 1880344, 1880345. b
Model
CS-11120-03M
UDI
B278CS1112003M0
Lot #
1880346, 1880347, 1880348, 1880349, 1880350, 1880351 — +25 moreShow all
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
Model
CS-13120-03M
Show 8 more code fields
UDI
B278CS1312003M0
Lot #
1880377, 1880378, 1880379, 1880380, 1880381, 1880382 — +27 moreShow all
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
Model
CS-15120-03M
UDI
B278CS1512003M0
Lot #
1880410, 1880411, 1880412, 1880413, 1880414, 1880415, 1880416, 1880417, 1880418, 1880419, 1880420, 1880421, 1880422, 1880423, 1880424, 1880425
Model
CS-17120-03M
UDI
B278CS1712003M0
Lot #
1880426, 1880427, 1880428, 1880429, 1880430, 1880431 — +23 moreShow all
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

What the firm 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.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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