Recall Z-0581-2015— ConforMIS, Inc.

Name: FDA recall Z-0581-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-19

Class II · Terminated

Class II FDA medical device recall by ConforMIS, Inc., initiated 2014-11-19, terminated 2015-10-08. It names one FDA 510(k) clearance: K140423. Product: Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.. Reason: Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting.

Recalling firm: ConforMIS, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-11-19
Terminated: 2015-10-08
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K140423 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.·cleared 2014-05-27

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

Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.

Reason for recall

Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting

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