Recall Z-2480-2019— OMNIlife science Inc.

Name: FDA recall Z-2480-2019
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 Insert Liner 51-28; Product code: H6-25128. 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 Insert Liner 51-28; Product code: H6-25128

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.