CLASS II Device recall · Reported 11 Sep 2019 · FDA Enforcement Report
ApeX acetabular liner hip prosthesis component ApeX-LNK recalled
OMNIlife science is recalling OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK, distributed nationwide in the US. The recall was initiated on 23 Jul 2019 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-2481-2019
- FDA event ID
- 83528
- Recalling firm
- OMNIlife science, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jul 2019
- FDA classified
- 5 Sep 2019
- Reported
- 11 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 23 Jul 2019 | Recall initiated by company | |
| 5 Sep 2019 | Classified by FDA | +44 days |
| 11 Sep 2019 | Published in enforcement report | +6 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 failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Product as listed by the FDA
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
Where it was distributed
US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
Nationwide AlabamaColoradoFloridaIllinoisMarylandNew YorkOklahomaPennsylvaniaUtah
Questions about this recall
Is ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 recalled?
Yes. OMNIlife science recalled ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 on 23 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2481-2019.
Why was it recalled?
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Which lots are affected?
LOT # 31707
Where was it sold?
US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
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 47/28- ApeX-LNK Poly Liner recalled | OMNIlife science | Other | 5 states |
| 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 |
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|---|---|---|---|---|---|
| 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 |