medical Class II Updated 2025-06-04

Onkos Surgical, Inc. recalls Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Number

Recalled Product

Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM


Hazard / Issue

Potential for breach of Tyvek seals.

Issued by

FDA

Affected States: MS, GA, TX, WA, LA, NJ, FL, AZ, MD, KS, IL, WI, KY, PA, NC, NE, OH, HI
Lot/Code Info: a. Model Number: CB-11152-03M; UDI-DI: B278CB1115203M0; Lot Numbers: 1880259, 1880260, 1880261, 1880262, 1880263, 1880264, 1880265, 1880266, 1880267, 1880268, 1880269, 1880270, 1880271, 1880272, 1880273, 1880274. b. Model Number: CB-13152-03M; UDI-DI: B278CB1315203M0; Lot Numbers: 1880275, 1880276, 1880277, 1880278, 1880279, 1880280, 1880281, 1880282, 1880283, 1880284. c. Model Number: CB-15152-03M; UDI-DI: B278CB1515203M0; Lot Numbers: 1880285, 1880286, 1880287, 1880288, 1880289, 1880290, 1880291, 1880292, 1880293, 1880294, 1880295, 1880296. d. Model Number: CB-17152-03M; UDI-DI: B278CB1715203M0; Lot Numbers: 1880297, 1880298, 1880299, 1880300, 1880301, 1880302, 1880303, 1880304, 1880305, 1880306, 1880307.
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