Recall Z-0225-2015— Medacta Usa

Name: FDA recall Z-0225-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-21

Class II · Terminated

Class II FDA medical device recall by Medacta Usa, initiated 2014-10-21, terminated 2016-03-14. It names one FDA 510(k) clearance: K110927. Product: The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.. Reason: The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery..

Recalling firm: Medacta Usa
Classification: Class II
Status: Terminated
Initiated: 2014-10-21
Terminated: 2016-03-14
Firm location: Chicago, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K110927 — MECTALIFMedacta International·cleared 2011-06-13

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

The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.

Reason for recall

The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.

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