Recall Z-2428-2020— PROVIDENCE MEDICAL TECHNOLOGIES
Class II · Terminated
Class II FDA medical device recall by PROVIDENCE MEDICAL TECHNOLOGIES, initiated 2019-03-29, terminated 2022-05-27. It names one FDA 510(k) clearance: K121713. 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: There may be dimensional manufacturing error that represents a potential safety risk to patients..
- Recalling firm
- PROVIDENCE MEDICAL TECHNOLOGIES
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-29
- Terminated
- 2022-05-27
- Firm location
- Pleasanton, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.