PROVIDENCE MEDICAL TECHNOLOGIES recalls Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint…

Recall date

March 29, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2428-2020

FDA classification

Class II

Brand / firm

PROVIDENCE MEDICAL TECHNOLOGIES

Sold / distributed

US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, LA, MA, MO, NC, NJ, NY, OH, OR and TX.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.