Recall Z-1079-2019— Conformis, Inc.

Name: FDA recall Z-1079-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-04

Class II · Terminated

Class II FDA medical device recall by Conformis, Inc., initiated 2019-01-04, terminated 2020-06-29. It names one FDA 510(k) clearance: K161668. Product: iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102. Reason: The labeling of the boxes and sterile pouches did not match the contents..

Recalling firm: Conformis, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-01-04
Terminated: 2020-06-29
Firm location: Billerica, 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

iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102

Reason for recall

The labeling of the boxes and sterile pouches did not match the contents.

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