Class II

Medical Device Recall: 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

Onkos Surgical, Inc. · September 1, 2023

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.

States Affected

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

Quantity Affected

49 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1880-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.