CLASS II Device recall · Reported 27 Aug 2014 · FDA Enforcement Report
Apex Arc Hip Stem, Size 2, HA Coated recalled by Omnilife Science
Omnilife Science is recalling Apex Arc Hip Stem, Size 2, HA Coated, distributed in 7 states. The recall was initiated on 9 May 2014 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-2241-2014
- FDA event ID
- 68527
- Recalling firm
- Omnilife Science, East Taunton, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 May 2014
- FDA classified
- 15 Aug 2014
- Reported
- 27 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 9 May 2014 | Recall initiated by company | |
| 15 Aug 2014 | Classified by FDA | +98 days |
| 27 Aug 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Staining on hip implant.
Product as listed by the FDA
Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
Where it was distributed
US: CA, OK, VA, FL, MA, NY, TX
Questions about this recall
Is Apex Arc Hip Stem, Size 2, HA Coated recalled?
Yes. Omnilife Science recalled Apex Arc Hip Stem, Size 2, HA Coated on 9 May 2014. The recall is Class II and its status is Terminated. Recall number Z-2241-2014.
Why was it recalled?
Staining on hip implant.
Which lots are affected?
Lot: 17284
Where was it sold?
US: CA, OK, VA, FL, MA, NY, TX
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 |
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 |