Devices

Device Recall cortical bone screw

Model / Serial
Lot code 203214
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution: USA including FL, GA, MI, MN, NY, TX, VA and countries of United Kingdom, Herzeles, South Korea, South Africa, China, and Milan
Product Description
Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR || Intended use: Acumed intramedullary rods and screws are designed to provide fixation of humeral, forearm and fibula fractures while they heal.
Manufacturer
Acumed LLC
1 Event
- Recall of Device Recall cortical bone screw

Manufacturer

Acumed LLC

Manufacturer Address
Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
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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