FDA Device recall Z-2762-2026
SeaSpine Polyaxial Head REF Number: 41-3010
- FDA Device
- Class II
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class II recall of SeaSpine Polyaxial Head REF Number: 41-3010 by Seaspine Orthopedics, citing due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2762-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-28 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Seaspine Orthopedics |
| Distribution | US |
Product
SeaSpine Polyaxial Head REF Number: 41-3010
Reason
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Identifiers
| code_info | UDI: 10889981155117; Affected Lots: AW199682G, AW199684G. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2762-2026%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.