FDA Device recall Z-0223-2020
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
- FDA Device
- Class II
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery by Synthes Usa Products, citing the subject product measures 4.0mm in diameter instead of 3.5mm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0223-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-16 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Synthes Usa Products |
| Distribution | NJ |
Product
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Reason
The subject product measures 4.0mm in diameter instead of 3.5mm.
Identifiers
| code_info | 10L2702 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0223-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.