FDA Device recall Z-0352-2018
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
- FDA Device
- Class II
- terminated
- Published 2018-01-24
On 2018-01-24 the FDA classified a Class II recall of Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R by Medtronic Sofamor Danek Usa, citing medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0352-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-06 |
| Published | 2018-01-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | n/a |
Product
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Reason
Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
Identifiers
| code_info | UDI 00643169097254 Lot Numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459…UDI 00643169097254 Lot Numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575 |
|---|
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-0352-2018%22
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