ConforMIS, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0991-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: October 31, 2016

Date Posted: January 18, 2017

Recall Number: Z-0991-2017

Event ID: 75969

Reason for Recall:

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

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial Number: 0384180

Distribution Pattern:

Distribution to TX only

Voluntary or Mandated:

Voluntary: Firm initiated