Cypher MIS Screw System-The system includes screws — Class II medical device recall Z-0909-2015
Terminated recall by Ebi, Llc, reported 2015-01-14, distributed in AL, CA, CT, IN, LA, NC, NJ, TX…. Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the
| Recall number | Z-0909-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ebi, Llc, Parsippany, NJ, United States |
| Recall initiated | 2014-10-08 |
| Classified | 2015-01-05 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2015-12-21 |
| Distributed | AL, CA, CT, IN, LA, NC, NJ, TX, WI |
| Countries outside the US | NL |
| Reason classes | device malfunction |
| Model numbers | 10.5X45MM, 14-571845, 5.5TI |
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 for recall
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.
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-0909-2015. 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.