Recall Z-0396-2014— Synthes USA HQ, Inc.

Name: FDA recall Z-0396-2014
Creator: U.S. Food and Drug Administration
Published: 2012-09-07

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2012-09-07, terminated 2015-12-18. It names one FDA 510(k) clearance: K113044. Product: Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.. Reason: This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-09-07
Terminated: 2015-12-18
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

Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.

Reason for recall

This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.

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