Onkos Surgical, Inc. recalls Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-1412

Recalled June 4, 2025 · FDA recall Z-1881-2025 · Onkos Surgical

Hazard

Potential for breach of Tyvek seals. · FDA Class II

Units

120 units

Sold at

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.

Description

Potential for breach of Tyvek seals.

Product

Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM

Manufacturer(s)

Onkos Surgical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →