KYPHON — Class II medical device recall Z-2247-2017
Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2017-06-14. The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening o
| Recall number | Z-2247-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2017-05-17 |
| Classified | 2017-06-03 |
| Reported by FDA | 2017-06-14 |
| Terminated | 2019-06-18 |
| Quantity | 17,657 units |
| Model numbers | F04C |
Product
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2247-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.