FDA Device recall Z-0909-2015
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws
- FDA Device
- Class II
- terminated
- Published 2015-01-14
On 2015-01-14 the FDA classified a Class II recall of Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws by Ebi, citing inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0909-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-08 |
| Published | 2015-01-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ebi |
| Distribution | AL, CA, CT, IN, LA, NC, NJ, TX, WI |
Product
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
Reason
Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
Identifiers
| code_info | Item Number: 14-571845 5.5 TI 10.5X45MM CANN TRANS 14-571850 5.5 TI 10.5X50MM CANN TRANS 14-571855 5.5 TI 10.5X55MM…Item Number: 14-571845 5.5 TI 10.5X45MM CANN TRANS 14-571850 5.5 TI 10.5X50MM CANN TRANS 14-571855 5.5 TI 10.5X55MM CANN TRANS 14-571860 5.5 TI 10.5X60MM CANN TRANS 14-571865 5.5 TI 10.5X65MM CANN TRANS 14-571870 5.5 TI 10.5X70MM CANN TRANS 14-571875 5.5 TI 10.5X75MM CANN TRANS 14-571880 5.5 TI 10.5X80MM CANN TRANS 14-571885 5.5 TI 10.5X85MM CANN TRANS 14-571890 5.5 TI 10.5X90MM CANN TRANS 14-571895 5.5 TI 10.5X95MM CANN TRANS 14-571899 5.5 TI 10.5X100MM CANN TRANS |
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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-0909-2015%22
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