FDA Device recall Z-2292-2013
Solitaire-35 Peek Solitaire Anterior Spinal System
- FDA Device
- Class II
- terminated
- Published 2013-10-09
On 2013-10-09 the FDA classified a Class II recall of Solitaire-35 Peek Solitaire Anterior Spinal System by Ebi, citing several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2292-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-09 |
| Published | 2013-10-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ebi |
| Distribution | US |
Product
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
Reason
Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
Identifiers
| code_info | 14-535140 12 mm 6-deg narrow 2327561 October-22 2302271 April-22 14-535141 14mm 6-deg narrow 2327661 Novembe…14-535140 12 mm 6-deg narrow 2327561 October-22 2302271 April-22 14-535141 14mm 6-deg narrow 2327661 November-22 2302281 April-22 14-535142 16mm 6-deg narrow 2327691 December-22 2302291 April-22 14-535143 18 mm 6-deg narrow 2327701 December-22 2302301 April-22 14-535144 20mm 6-deg narrow 2327711 December-22 2302301 April-22 14-535144 20 mm 6-deg narrow 2302311 June-22 14-535150 12mm 12-deg narrow 2327711 December-22 2302321 April-22 14-535151 14mm 12-deg narrow 2327601 October-22 2302332 April-22 14-535152 16mm12-deg narrow 2327671 November-22 2302341 April-22 14-535153 18 mm 12-deg narrow 2327751 December-22 2302351 April-22 14-535154 20 mm 12-deg narrow 2327571 December-22 2327571 November-22 2302361 April-22 14-535170 12mm 6-deg medium 2327631 October-22 2302371 April-22 14-5351711 14 mm 6-deg medium 2327641 October-22 2302381 April-22 14-535172 16 mm 6-deg medium 2327761 Decembe |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2292-2013%22
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