Device 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
Z-1823-2015
Product summary
- Event
- Event 71357
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75 units
- Official record key
device-enforcement:Z-1823-2015
Official wording
Reason: The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
Code information: 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.
Distribution pattern: Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.
Derived failure modes
-
Unknown
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.