Recall Z-2479-2019— OMNIlife science Inc.

Name: FDA recall Z-2479-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-23

Class II · Terminated

Class II FDA medical device recall by OMNIlife science Inc., initiated 2019-07-23, terminated 2020-04-24. It names one FDA 510(k) clearance: K111572. Product: OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328. Reason: Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery..

Recalling firm: OMNIlife science Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-07-23
Terminated: 2020-04-24
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K111572 — NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODELSerf·cleared 2011-08-29

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

OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328

Reason for recall

Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.

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