FDA Device recall Z-0920-2021
SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner
- FDA Device
- Class II
- terminated
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner by Omnilife Science, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0920-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-21 |
| Published | 2021-02-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Omnilife Science |
| Distribution | AL, ID, MD, NY, OK |
Product
SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128
Reason
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
Identifiers
| code_info | Lot Number: 28413 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0920-2021%22
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