Devices

Device Recall PFC Sigma Round Dome Patella

Model / Serial
Product code 960112, Lot number 3292209
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide distribution: CA, MI, NJ and WI.
Product Description
PFC Sigma Round Dome Patella 38 MM 3 Peg || Device is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacrylate (PMMA) bone cement.
Manufacturer
DePuy Orthopaedics, Inc.
1 Event
- Recall of Device Recall PFC Sigma Round Dome Patella

Manufacturer

DePuy Orthopaedics, Inc.

Manufacturer Address
DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
Manufacturer Parent Company (2017)
Johnson & Johnson
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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