Z-1879-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 4, 2025
- Initiation Date
- September 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 147 units
Product Description
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
Reason for Recall
Potential for breach of Tyvek seals.
Distribution Pattern
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.
Code Information
a. Model Number: 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. Model Number: CS-10100-03M. UDI-DI: B278CS1010003M0. Lot Numbers: 1880334, 1880335, 1880336, 1880337, 1880338, 1880339, 1880340, 1880341, 1880342, 1880343, 1880344, 1880345. b. Model Number: 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. Model Number: 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. Model Number: CS-15120-03M; UDI-DI: B278CS1512003M0; Lot Numbers: 1880410, 1880411, 1880412, 1880413, 1880414, 1880415, 1880416, 1880417, 1880418, 1880419, 1880420, 1880421, 1880422, 1880423, 1880424, 1880425. Model Number: 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.