SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner — Class II medical device recall Z-0920-2021
Terminated recall by OMNIlife science Inc., reported 2021-02-03, distributed in AL, ID, MD, NY, OK. Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher
| Recall number | Z-0920-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OMNIlife science Inc., Raynham, MA, United States |
| Recall initiated | 2020-12-21 |
| Classified | 2021-01-26 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2021-06-10 |
| Distributed | AL, ID, MD, NY, OK |
| Quantity | 3 units |
| Lot numbers | 28413 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0920-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.