Devices

Device Recall Stableloc (TM) External Fixation System

Model / Serial
Part number (REF): FX-4001-S; Lot numbers (Work order #): W53416, W53682, W53683, and W53684.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution -- USA, including states of VA, NC, FL, ME, WA, GA, TX and PA and countries of Spain, Japan and Greece.
Product Description
Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed by: Acumed (R) 5885 NW Cornelius Pass Road, Hillsboro, OR 97124...STERILE"
Manufacturer
Acumed LLC
1 Event
- Recall of Device Recall Stableloc (TM) External Fixation System

Manufacturer

Acumed LLC

Manufacturer Address
Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9370
Manufacturer Parent Company (2017)
Acumed Llc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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