CLASS II Device recall · Reported 2 Sep 2015 · FDA Enforcement Report
Offset Femoral Alignment Guide x 6¿; Product recalled
Omnilife Science is recalling Offset Femoral Alignment Guide x 6¿, distributed nationwide in the US. The recall was initiated on 9 Jun 2015 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-2454-2015
- FDA event ID
- 71470
- Recalling firm
- Omnilife Science, East Taunton, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jun 2015
- FDA classified
- 24 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 9 Jun 2015 | Recall initiated by company | |
| 24 Aug 2015 | Classified by FDA | +76 days |
| 2 Sep 2015 | 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
The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
Product as listed by the FDA
Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
Where it was distributed
Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.
Questions about this recall
Why was it recalled?
The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
Which lots are affected?
Lot Numbers: MM0314R, VA0713, Z1111
Where was it sold?
Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.
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.
Other products in this recall event
1 other product · FDA event 71470This product is part of a recall event; the main page for the event is Offset Femoral Alignment Guide x 6¿; Product recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Offset Femoral Alignment Guide x 6¿; Product recalled | Omnilife Science | Other | Nationwide |
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 | 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 | 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 |