FDA-Device2017-07-05Class II

ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E

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 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2646-2017

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