Recall Z-0001-2013 ยท NKB Thoracolumbosacral Pedicle Screw System
Synthes USA HQ, Inc.
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
| Date | Oct 1, 2012 (initiated Jun 18, 2012) |
| Status | Terminated |
| Reason | Synthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints. Synthes has identified technique measures and has updated the labeling associated with this system. The labeling reflects updated technique recommendations and emphasizes the importance of avoiding rod mis-alignment. |
| Root cause | Labeling design |
| Action | SYNTHES sent an Urgent Medical Device Labeling Correction letter dated June 18, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to replace the previous version of the labeling with the new labeling provided. In addition, they can access an electronic version of the labeling by accessing Product Literature at the following link: http://us.synthes.com. The new version can be identified by code J11031-B located at the bottom right corner of the back cover. To confirm their receipt and understanding of the informa |
| Quantity | 1602 |
| Distribution | Nationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113044 | SYNTHES MIRS Synthes Spine, Dec 21, 2011 |