Fortex" Pedicle Screw System Continuous Radius Rod 5 — Class II medical device recall Z-1823-2015
Terminated recall by X Spine Systems Inc, reported 2015-07-01, distributed in FL, ID, IL, KS, LA, MI, MO, NJ…. The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
| Recall number | Z-1823-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | X Spine Systems Inc, Miamisburg, OH, United States |
| Recall initiated | 2015-04-07 |
| Classified | 2015-06-22 |
| Reported by FDA | 2015-07-01 |
| Terminated | 2015-10-01 |
| Distributed | FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA, TX |
| Countries outside the US | AT, DE, IT |
| Quantity | 75 units |
| Lot numbers | 2943-01 |
| Serial numbers | 46118, 46581, 47296, 47588, 47653, 48164, 48201, 48412, 49156, 49585, 49586, 49649, G22, G45, G47, G77, G83, G87X, G90X, R15, XP03, XP21, XP27, XP28, XP29 and 1 more |
| Model numbers | N60001068 |
Product
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
Reason for recall
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
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-1823-2015. 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.