Z-2428-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2020
- Initiation Date
- March 29, 2019
- Termination Date
- May 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 208 units
Product Description
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 Pattern
US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, LA, MA, MO, NC, NJ, NY, OH, OR and TX.
Code Information
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