FDA Device

Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.

Hazard

On 3/9/10 it was discovered that the recalling firm packaged MFT-021-35-24 Screws from lot 0964092 as MFT-021-35-22 lot 0964081.

What You Should Do

Remedy

OrthoHelix Surgical Designs, Inc. issued an "Important Field Correction Notice" dated March 23, 2010 via FedEx overnight. They instructed their customers to inventory their stock for affected product. All affected product will be replaced by the firm. For further information, contact OrthoHelix Surgical Designs, Inc. at 1-330-247-1444.

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Products

Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. Intended as a guide to normal healing and are not intended to replace normal b
Brand
Orthohelix Surgical Designs Inc
UPC
Lot Number: 0964081

Units Affected

62 pieces

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