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.
Reported: July 1, 2020 Initiated: March 29, 2019 #Z-2428-2020
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.
Details
- Recalling Firm
- PROVIDENCE MEDICAL TECHNOLOGIES
- Units Affected
- 208 units
- Distribution
- US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, LA, MA, MO, NC, NJ, NY, OH, OR and TX.
- Location
- Pleasanton, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by PROVIDENCE MEDICAL TECHNOLOGIES. Units affected: 208 units.
Why was this product recalled? ▼
There may be dimensional manufacturing error that represents a potential safety risk to patients.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2020. Severity: Moderate. Recall number: Z-2428-2020.
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