Recall Z-0169-2020— OMNIlife science Inc.

Name: FDA recall Z-0169-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-11

Class II · Terminated

Class II FDA medical device recall by OMNIlife science Inc., initiated 2019-09-11, terminated 2020-04-27. It names one FDA 510(k) clearance: K060072. Product: OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.. Reason: Stems missing porous coating on the device..

Recalling firm: OMNIlife science Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-09-11
Terminated: 2020-04-27
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K060072 — MONOBLOCK PRESS-FIT HIP STEMOmni Life Science, Inc.·cleared 2006-08-24

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

OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.

Reason for recall

Stems missing porous coating on the device.

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