Recall Z-0991-2017— ConforMIS, Inc.

Name: FDA recall Z-0991-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-31

Class II · Terminated

Class II FDA medical device recall by ConforMIS, Inc., initiated 2016-10-31, terminated 2017-01-11. It names one FDA 510(k) clearance: K161668. Product: ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. Reason: iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm)..

Recalling firm: ConforMIS, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-10-31
Terminated: 2017-01-11
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K161668 — ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.·cleared 2016-07-15

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 PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis

Reason for recall

iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).

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