FDA recall Z-0922-2021

Product

SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928

Reason for recall

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

Distribution

AL, ID, MD, NY, OK

Key facts

Status

Terminated

Initiation date

2020-12-21

Report date

2021-02-03

Termination date

2021-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0922-2021