FDA recall Z-2428-2020

PROVIDENCE MEDICAL TECHNOLOGIES · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-03-29
Report date
2020-07-01
Termination date
2022-05-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pleasanton, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2428-2020