FDA Device recall Z-1823-2015
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone:…
- FDA Device
- Class II
- terminated
- Published 2015-07-01
On 2015-07-01 the FDA classified a Class II recall of Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone:… by X Spine Systems, citing the Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1823-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-07 |
| Published | 2015-07-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | X Spine Systems |
| Distribution | FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA, TX |
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
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
Identifiers
| code_info | Model #: N60001068; Lot #: 2943-01; Serial #s: 46118, 46581, 47296, 47588, 47653, 48164, 48201, 48412, 49156, 49585, 4…Model #: N60001068; Lot #: 2943-01; Serial #s: 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 & XP32. |
|---|
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-1823-2015%22
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