Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
This recall has been terminated (originally issued June 22, 2015).
- Company
- X Spine Systems Inc
- Recall Initiated
- April 7, 2015
- Posted
- June 22, 2015
- Terminated
- October 1, 2015
- Recall Number
- Z-1823-2015
- Quantity
- 75 units
- Firm Location
- Miamisburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
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.
Lot / Code Info
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.
Root 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.