Devices

Device Recall POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar)

Model / Serial
Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
Product Description
smith&nephew; POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only || The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument
Manufacturer
Smith & Nephew, Inc.
1 Event
- Recall of Device Recall POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar)

Manufacturer

Smith & Nephew, Inc.

Manufacturer Address
Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
Manufacturer Parent Company (2017)
Smith & Nephew plc
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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