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I Color Complete Lens (Intertrade) – Bacterial Contamination (2014)

A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses. I Color Color Complete brand color contact lenses are unapproved medical devices.

Class IIModerate

FDASep 10, 2014CA, FL, TX• Intertrade Imports Inc.

Persona Knee System (Zimmer) – Screw Defect (2014)

The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver.

Class IIModerate

FDASep 9, 2014Nationwide• Zimmer, Inc.

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I Color Complete Lens (Intertrade) – Bacterial Contamination (2014)

Persona Knee System (Zimmer) – Screw Defect (2014)

Buprenorphine HCl Injection (Hospira) – Impurity Specification Failure (2014)

VITROS 5600 System (Ortho-Clinical) – Software Anomaly (2014)

Titanium Fixation Screws (Instrumed) – Marketing Compliance (2014)

CVB Distraction Screws (Instrumed) – Marketing Compliance (2014)

McKenzie Perforator Drills (Instrumed) – Marketing Compliance (2014)

Gardner-Wells Wrenches (Instrumed) – Marketing Compliance (2014)

McKenzie Enlarging Burrs (Instrumed) – Marketing Compliance (2014)

Hudson Braces (Instrumed) – Marketing Compliance (2014)

VITROS 4600 System (Ortho-Clinical) – Software Anomaly (2014)

Cushing Burrs (Instrumed) – Marketing Compliance (2014)

Titanium Traction Tong Nuts (Instrumed) – Marketing Compliance (2014)

Manual Bunnell Cranial Drills (Instrumed) – Marketing Compliance (2014)

Circumcision Clamp (Instrumed) – Marketing Compliance (2014)

Endometrial Suction Curette (Instrumed) – Marketing Compliance (2014)

External Vein Stripper (Instrumed) – Marketing Compliance (2014)

Replacement Traction Tongs (Instrumed) – Marketing Compliance (2014)

Hudson Cerebellar Extensions (Instrumed) – Marketing Compliance (2014)

Hudson Burrs (Instrumed) – Marketing Compliance (2014)