medical Class II Updated 2020-07-01

PROVIDENCE MEDICAL TECHNOLOGIES recalls Ally Bone Screw - Product Usage:Bone Screws are indicated fo

Recalled Product

Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only.

Hazard / Issue

There may be dimensional manufacturing error that represents a potential safety risk to patients.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number; PD 32 601 - ALLY Bone Screw L 10mm Lot Number: 046164 Model Number: PD 32 602 - ALLY Bone Screw L 12mm Lot Numbers: 045375 045646 045647 046313
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