Recall Z-0600-2018— ConforMIS, Inc.

Name: FDA recall Z-0600-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-24

Class II · Terminated

Class II FDA medical device recall by ConforMIS, Inc., initiated 2017-07-24, terminated 2019-02-01. It names one FDA 510(k) clearance: K161668. Product: 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.. Reason: Implant kit mislabeled.

Recalling firm: ConforMIS, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-24
Terminated: 2019-02-01
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

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.

Reason for recall

Implant kit mislabeled

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