FDA-Device2021-02-03Class II
SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728
OMNIlife science Inc.
Hazard
Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
Sold states
AL, ID, MD, NY, OK
Affected count
3 units
Manufactured in
480 Paramount Dr, Raynham, MA, United States
Products
SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0921-2021Don'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