Devices

Device Recall The Polarus Plus Humeral Rod

Model / Serial
LOT 266220
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Italy, Ireland, and Great Britain.
Product Description
The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is labeled in part: "Polarus Humeral Fixation System Size: 8mm X 240mm Polarus Plus Humeral Rod***Titanium***REF HR-0824-S***LOT 266220***RX only***Manufactured or distributed by: ACUMED 5885 NW Cornelius Pass Road Hillsboro, OR 97124 USA***"
Manufacturer
Acumed LLC
1 Event
- Recall of Device Recall The Polarus Plus Humeral Rod

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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