FDA-Device2019-09-11Class II
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
OMNIlife science Inc.
Hazard
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Sold states
US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
Affected count
14 units
Manufactured in
480 Paramount Dr, N/A, Raynham, MA, United States
Products
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2479-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief