Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
- Company
- Onkos Surgical, Inc.
- Recall Initiated
- September 1, 2023
- Posted
- May 29, 2025
- Recall Number
- Z-1884-2025
- Quantity
- 99 units
- Firm Location
- Parsippany, NJ
Reason for Recall
Potential for breach of Tyvek seals.
Distribution
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.
Lot / Code Info
a. Model Number: 25001040E; UDI-DI: B27825001040E0; Lot Numbers: 1802695, 1813688, 1823008, 1833874, 1841365, 1844552, 1855654, 1855799, 1856873, 1856874, 1860075, 1860076, 1880172, 1880173, 1880174, 1880175, 1880176, 1880177, 1880178, 1880179, 1880180, 1880181, 1880182. b. Model Number: 25001050E; UDI-DI: B27825001050E0; Lot Numbers: 1880183, 1880184, 1880185, 1880186, 1880187, 1880188, 1880189, 1880190, 1880191, 1880192, 1880193, 1880194, 1880195, 1880196. c. Model Number: 25001060E; UDI-DI: B27825001060E0; Lot Numbers: 1880197, 1880198, 1880199, 1880200, 1880201, 1880202, 1880203, 1880204, 1880205. d. Model Number: 25001070E; UDI-DI: B27825001070E0; Lot Numbers: 1880206, 1880207, 1880208, 1880209, 1880210, 1880211, 1880212, 1880213, 1880214, 1880215, 1880216, 1880217. e. Model Number: 25001090E; UDI-DI: B27825001090E0; Lot Numbers: 1880218, 1880219, 1880220, 1880221, 1880222, 1880223, 1880224, 1880225, 1880226, 1880227, 1880228, 1880229, 1880230, 1880231, 1880232. f. Model Number: 25001110E; UDI-DI: B27825001110E0; Lot Numbers: 1880233, 1880234, 1880235, 1880236, 1880237, 1880238, 1880239, 1880240, 1880241, 1880242, 1880243, 1880244, 1880245. g. Model Number: 25001140E; UDI-DI: B27825001140E0; Lot Numbers: 1880246, 1880247, 1880248, 1880249, 1880250, 1880251, 1880252, 1880253, 1880254, 1880255, 1880256, 1880257, 1880258.
Root Cause
Packaging change control
Action Taken
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.