CLASS II Device recall · Reported 3 Feb 2021 · FDA Enforcement Report
SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner recalled
OMNIlife science is recalling SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner, distributed in Alabama, Idaho, Maryland, New York, Oklahoma. The recall was initiated on 21 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0921-2021
- FDA event ID
- 87062
- Recalling firm
- OMNIlife science, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Dec 2020
- FDA classified
- 26 Jan 2021
- Reported
- 3 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 21 Dec 2020 | Recall initiated by company | |
| 26 Jan 2021 | Classified by FDA | +36 days |
| 3 Feb 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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
Where it was distributed
AL, ID, MD, NY, OK
Questions about this recall
Is SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner recalled?
Yes. OMNIlife science recalled SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner on 21 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-0921-2021.
Why was it recalled?
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
Which lots are affected?
Lot Number: 28624
Where was it sold?
AL, ID, MD, NY, OK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from OMNIlife science
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OMNI K2 Hip Stem, Manufacturer's Product recalled by OmniLife Science | OmniLife Science | Lead & Heavy Metals | CO, VA |
| Device | CLASS II | SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner recalled | OMNIlife science | Other | 5 states |
| Device | CLASS II | SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner recalled | OMNIlife science | Other | 5 states |
| Device | CLASS II | OMNI Hip System recalled by OMNIlife science | OMNIlife science | Other | IL, OK |
| Device | CLASS II | ApeX acetabular liner hip prosthesis component Serf Dual recalled | OMNIlife science | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |