FDA Device recall Z-1636-2021
EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
- FDA Device
- Class II
- terminated
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class II recall of EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS by Biopsybell S R L, citing products labeled as sterile were distributed, but may not have been sterilized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1636-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-22 |
| Published | 2021-05-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biopsybell S R L |
| Distribution | US |
Product
EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
Reason
Products labeled as sterile were distributed, but may not have been sterilized.
Identifiers
| code_info | BATCH:2003721 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1636-2021%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.