FDA-Device2025-06-04Class II
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.
Hazard
Potential for breach of Tyvek seals.
Sold states
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.
Affected count
49 units
Manufactured in
77 E Halsey Rd, N/A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1880-2025Don't want to check this manually?
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