Devices

Reverse Shoulder Prosthesis System

Model / Serial
Model Number 508-00-000: lot #s: 848C1078, 848C1079, 848C1080, 848C1081, 848C1082, 848C1083, 848C1084, 848C1085, 848C1086, 848C1087 Model number: 508-00-008, lot #'s: 854C1016
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution--USA (nationwide) including the states of CA, FL, IL, LA, MA, MD, ME, NM, NY, OK, PA, SC, TN, TX, UT, and WA and the countries of Germany, Italy, and United Kingdom.
Product Description
Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. || The Reverse Shoulder Prosthesis (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant (s), and a functional deltoid muscles in necessary to use the device.
Manufacturer
Encore Medical, Lp
1 Event
- Recall of Reverse Shoulder Prosthesis System

Manufacturer

Encore Medical, Lp

Manufacturer Address
Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
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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