KYPHON EXPRESS — Class II medical device recall Z-1057-2015
Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2015-02-11, distributed nationwide. The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain
| Recall number | Z-1057-2015 |
|---|---|
| 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 | 2015-01-13 |
| Classified | 2015-02-05 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2015-07-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 239 units |
| Reason classes | labeling |
| Model numbers | 1EA, T34A |
Product
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
Reason for recall
The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
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-1057-2015. 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.