Medtronic KYPHON — Class II medical device recall Z-0352-2018
Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2018-01-24. Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align w
| Recall number | Z-0352-2018 |
|---|---|
| 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 | 2017-12-06 |
| Classified | 2018-01-14 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2019-11-04 |
| Countries outside the US | AT, BE, BG, CA, DE, FR, IT, LB, LU, PT, ZA |
| Quantity | 3,319 units |
| UPC / GTIN / UDI-DI | 00643169097254 |
| Lot numbers | WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472176, WI472177, WI472178, WI474575 |
Product
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Reason for recall
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.
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-0352-2018. 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.