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.

Recall Insight

This FDA Devices action (record #Z-2428-2020) was formally reported on July 1, 2020, with the manufacturer initiating the action on March 29, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. PROVIDENCE MEDICAL TECHNOLOGIES is listed as the recalling firm, operating out of Pleasanton, CA. Federal records indicate 208 units units are affected.

The documented reason for this recall is: There may be dimensional manufacturing error that represents a potential safety risk to patients. Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, LA, MA, MO, NC, NJ, NY, OH, OR and TX.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.