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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