Recall Z-1823-2015
X Spine Systems Inc · initiated April 7, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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.
Reason for recall
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
FDA-determined cause: Other
Action taken
X-Spine sent an Urgent Medical Device Recall Letter dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: 1. The affected hospital and surgeon should be notified of this recall immediately. 2. Complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately. a. Reference RMA # 5410 b. Use enclosed shipping label 3. No action should be taken with product that has been implanted. Please feel free to contact me at 800.903.0640 ext. 137.
Details
- Recall number
- Z-1823-2015
- Initiated
- April 7, 2015
- Posted by FDA
- June 22, 2015
- Terminated
- October 1, 2015
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Quantity
- 75 units
- Distribution
- 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.
- Recalling firm
- X Spine Systems Inc, Miamisburg, OH