Solitaire-35 Peek Solitaire Anterior Spinal System — Class II medical device recall Z-2292-2013
Terminated recall by Ebi, Llc, reported 2013-10-09, distributed nationwide. Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 3
| Recall number | Z-2292-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ebi, Llc, Parsippany, NJ, United States |
| Recall initiated | 2013-04-09 |
| Classified | 2013-09-27 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2014-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 1,730 units |
Product
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
Reason for recall
Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
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-2292-2013. 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.