Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2646-2017 — ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E

U.S. FDA — Device Enforcement · United States · 2017-05-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2646-2017
Date of alert
2017-05-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Onkos Surgical, Inc.
Product category
device
Product type
Devices
Reported risk: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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