FDA Device recall Z-2214-2013
Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054 by Ebi, citing several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2214-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-13 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ebi |
| Distribution | US |
Product
Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662
Reason
Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
Identifiers
| code_info | 14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029 14-501661 Rod Reducer Lots IT0015 IT002…14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029 14-501661 Rod Reducer Lots IT0015 IT0022 IT0023 14-501662 Counter Torque Lots IT0020 IT0021 |
|---|
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-2214-2013%22
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