FDAFDA · Food and drugs·Recall number Z-2428-2020
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.
Published July 1, 2020 · Recall initiated: March 29, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There may be dimensional manufacturing error that represents a potential safety risk to patients.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- PROVIDENCE MEDICAL TECHNOLOGIES
- Distributor
- US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, LA, MA, MO, NC, NJ, NY, OH, OR and TX.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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