🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: September 1, 2023 Onkos Surgical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Onkos Surgical, Inc.
Reason for Recall:
Potential for breach of Tyvek seals.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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

Product Codes/Lot Numbers:

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.

Distribution:

Distributed in: MS, GA, TX, WA, LA, NJ, FL, AZ, MD, KS, IL, WI, KY, PA, NC, NE, OH, HI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1879-2025

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