Recall Z-0001-2013— Synthes USA HQ, Inc.

Name: FDA recall Z-0001-2013
Creator: U.S. Food and Drug Administration
Published: 2012-06-18

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2012-06-18, terminated 2015-09-10. It names one FDA 510(k) clearance: K113044. 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).. 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..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-06-18
Terminated: 2015-09-10
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K113044 — SYNTHES MIRSSynthes Spine·cleared 2011-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.