Cypher MIS Screw System — Class II medical device recall Z-2214-2013
Terminated recall by Ebi, Llc, reported 2013-09-25, distributed nationwide. Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
| Recall number | Z-2214-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ebi, Llc, Parsippany, NJ, United States |
| Recall initiated | 2013-08-13 |
| Classified | 2013-09-17 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2015-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 427 units |
| Lot numbers | 14-501661, 14-501662, IT0015, IT0020, IT0021, IT0022, IT0023, IT0024, IT0025, IT0026, IT0027, IT0028, IT0029 |
| Model numbers | 14-501660, 14-501661, 14-501662 |
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 for recall
Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
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-2214-2013. 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.