Recall Z-0063-2020— Conformis, Inc.

Name: FDA recall Z-0063-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-22

Class II · Terminated

Class II FDA medical device recall by Conformis, Inc., initiated 2019-08-22, terminated 2020-07-08. It names one FDA 510(k) clearance: K162719. Product: iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right. Reason: Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging..

Recalling firm: Conformis, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-08-22
Terminated: 2020-07-08
Firm location: Billerica, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K162719 — iTotal® Hip Replacement SystemConformis, Inc.·cleared 2017-06-14

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 Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right

Reason for recall

Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.

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