FDA Device recall Z-1752-2021
InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures
- FDA Device
- Class II
- terminated
- Published 2021-06-09
On 2021-06-09 the FDA classified a Class II recall of InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures by Zavation, citing products distributed as sterile may not have been adequately sterilized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1752-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-25 |
| Published | 2021-06-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Zavation |
| Distribution | US |
Product
InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.
Reason
Products distributed as sterile may not have been adequately sterilized
Identifiers
| code_info | a) INTVM-15-FLDSK, Lot Numbers:10342ZV, 12525ZV, 12267ZV, 12011ZV, 10545ZV, 10048ZV, 11861ZV, 11343ZV, 11037ZV, 10780ZV…a) INTVM-15-FLDSK, Lot Numbers:10342ZV, 12525ZV, 12267ZV, 12011ZV, 10545ZV, 10048ZV, 11861ZV, 11343ZV, 11037ZV, 10780ZV, 11102ZV b) INTVM-20-FLDSK, Lot Numbers: 10312ZV, 11698ZV, 10276ZV, 10205ZV, 10031ZV |
|---|
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-1752-2021%22
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