Recall Z-0899-2022— Conformis, Inc.

Name: FDA recall Z-0899-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-22

Class II · Completed

Class II FDA medical device recall by Conformis, Inc., initiated 2022-02-22. It names one FDA 510(k) clearance: K210809. Product: iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101. Reason: Incorrect tibial base plate implant packaged in kit.

Recalling firm: Conformis, Inc.
Classification: Class II
Status: Completed
Initiated: 2022-02-22
Firm location: Billerica, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K210809 — iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.·cleared 2021-05-12

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 Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

Reason for recall

Incorrect tibial base plate implant packaged in kit

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