FDAFDA · Food and drugs·Recall number Z-2648-2017
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
Published July 5, 2017 · Recall initiated: May 23, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Onkos Surgical, Inc.
- Distributor
- AZ, IL & KS
- Lot
- LOT 1699599
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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