ConforMIS, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0600-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ 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: July 24, 2017

Date Posted: February 21, 2018

Recall Number: Z-0600-2018

Event ID: 78902

Reason for Recall:

Implant kit mislabeled

Status: Terminated

Product Quantity: 2 units

Code Information:

Serial numbers: 0398482 & 0399917 Expiration Date: 12/31/2017

Distribution Pattern:

US Distribution to the states of :CA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated