FDA-Device2017-07-05Class II
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
Onkos Surgical, Inc.
Hazard
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Sold states
AZ, IL & KS
Affected count
4 units
Manufactured in
77 E Halsey Rd, N/A, Parsippany, NJ, United States
Products
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2647-2017Don't want to check this manually?
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