Devices

Device Recall PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices

Model / Serial
Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS)
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.
Product Description
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) || Used during primary total knee arthroplasty to improve patient mobility.
Manufacturer
DePuy Orthopaedics, Inc.
1 Event
- Recall of Device Recall PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices

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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