Devices

Device Recall Empowr PS Knee Tibial Insert

Model / Serial
035U1000
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution to CO, NY, and FL
Product Description
Empowr PS Knee Tibial Insert; Model 343-14-709 || The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
Manufacturer
Encore Medical, Lp
1 Event
- Recall of Device Recall Empowr PS Knee Tibial Insert

Manufacturer

Encore Medical, Lp

Manufacturer Address
Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758-5445
Manufacturer Parent Company (2017)
The Blackstone Group LP
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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