Ally Bone Screw — Class II medical device recall Z-2428-2020
Terminated recall by PROVIDENCE MEDICAL TECHNOLOGIES, reported 2020-07-01, distributed nationwide. There may be dimensional manufacturing error that represents a potential safety risk to patients.
| Recall number | Z-2428-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PROVIDENCE MEDICAL TECHNOLOGIES, Pleasanton, CA, United States |
| Recall initiated | 2019-03-29 |
| Classified | 2020-06-25 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2022-05-27 |
| Distributed | Nationwide (US) |
| Quantity | 208 units |
| Lot numbers | 045375, 045646, 045647, 046164, 046313 |
| Model numbers | 601, 602 |
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 for recall
There may be dimensional manufacturing error that represents a potential safety risk to patients.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2428-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.