FDA Device recall Z-0603-2018
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool by Exactech, citing vix Bit may fracture during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0603-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-11 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exactech |
| Distribution | CA, FL |
Product
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Reason
Vix Bit may fracture during use.
Identifiers
| code_info | Catalog No. 531-15-08, Lot No. 75296003, 80129003, 81327001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0603-2018%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.