—#111690

Product

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).

FDA product code: NKB — Thoracolumbosacral Pedicle Screw System
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K113044
Affected lot / code info: Minimally Invasive Redution Screw System (MIRS) - Labeling number J11031-A

Why it was recalled

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 (FDA determination)

Labeling design

Action the firm took

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 information contained in the letter, the recall package also included a response form to be completed by consignee and returned to Synthes.by Fax: 610-251-9005 or Scan/email: FieldAction@Synthes.com. Customers with questions were asked to call 1-800-620-7025, ext 5403 or contact their Synthes Spine Sales Consultant. For questions regarding this recall call 610-719-5377. The firm initiated this recall action on June 18, 2012 by sending an Urgent Medical Device Labeling Correction letter to all accounts. The updated labeling was Included with the notification letter.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Nationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA.

Timeline

Recall initiated: 2012-06-18
Posted by FDA: 2012-10-01
Terminated: 2015-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111690. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.