Medical device recalls Moderate risk

Onkos Surgical, Inc. recalls ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLIN…

Recall date
May 23, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2646-2017
FDA classification
Class II
Brand / firm
Onkos Surgical, Inc.
Sold / distributed
AZ, IL & KS

Why it was recalled

The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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