Recall Z-2405-2023— Conformis, Inc.

Name: FDA recall Z-2405-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-16

Class II · Ongoing

Class II FDA medical device recall by Conformis, Inc., initiated 2023-06-16. It names 3 FDA 510(k) clearances: K221104, K202484, K190904. Product: CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO. Reason: 30mm screws were labeled as 25mm screws..

Recalling firm: Conformis, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-06-16
Firm location: Billerica, MA, United States

510(k) clearances named in this recall

3 on FDA's record

K221104 — Actera hip systemConformis, Inc.·cleared 2022-08-04
K202484 — Cordera Hip SystemConformis, Inc.·cleared 2020-09-24
K190904 — Conformis BeneFIT Hip SystemConformis, Inc.·cleared 2019-08-28

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

CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO

Reason for recall

30mm screws were labeled as 25mm screws.

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