Devices

Foundation Tibial Broach

Model / Serial
Lot#'s 35149L02, 36204L06, 37990L06, 38272L13, and 50479L12
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution - USA including AR, AZ, CA, LA, MD, NY, TX, UT and Puerto Rico and the countries of United Kingdom and Italy
Product Description
Foundation Tibial Broach P/N 801-01-013 || Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial Baseplate stem. P/N 801-01-013
Manufacturer
Encore Medical, Lp
1 Event
- Recall of Foundation Tibial Broach

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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