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

Recalled July 1, 2020 · FDA recall Z-2428-2020 · PROVIDENCE MEDICAL TECHNOLOGIES

Hazard
There may be dimensional manufacturing error that represents a potential safety risk to patients. · FDA Class II
Units
208 units
Sold at
US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, LA, MA, MO, NC, NJ, NY, OH, OR and TX.

Description

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

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.
Manufacturer(s)
PROVIDENCE MEDICAL TECHNOLOGIES

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

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