CLASS II Device recall · Reported 30 Oct 2019 · FDA Enforcement Report
OMNI Hip System recalled by OMNIlife science
OMNIlife science is recalling OMNI Hip System, distributed in Illinois, Oklahoma. The recall was initiated on 11 Sep 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-0169-2020
- FDA event ID
- 83844
- Recalling firm
- OMNIlife science, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Sep 2019
- FDA classified
- 21 Oct 2019
- Reported
- 30 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 11 Sep 2019 | Recall initiated by company | |
| 21 Oct 2019 | Classified by FDA | +40 days |
| 30 Oct 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stems missing porous coating on the device.
Product as listed by the FDA
OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
Where it was distributed
OK, IL
Questions about this recall
Why was it recalled?
Stems missing porous coating on the device.
Which lots are affected?
Lot # 33035
Where was it sold?
OK, IL
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 26 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 | Other | 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 | 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 | Device Malfunction | 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) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |