Onkos Surgical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1880-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 1, 2023

Date Posted: June 4, 2025

Recall Number: Z-1880-2025

Event ID: 96782

Reason for Recall:

Potential for breach of Tyvek seals.

Status: Ongoing

Product Quantity: 49 units

Code Information:

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated