FDA Device recall Z-2247-2017
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R
- FDA Device
- Class II
- terminated
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class II recall of KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R by Medtronic Sofamor Danek Usa, citing the directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2247-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-17 |
| Published | 2017-06-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | n/a |
Product
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Reason
The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.
Identifiers
| code_info | All Lots |
|---|
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-2247-2017%22
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