MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracol

FDA device recall Z-0001-2013 · posted 2012-10-01 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Labeling design

Status

Terminated

Product code

NKB

Quantity affected

1602

Distribution

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

Date initiated

2012-06-18

Date posted

2012-10-01

Date terminated

2015-09-10

Location

West Chester, PA

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