Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumen...
FDA Device Recall #Z-2454-2015 — Class II — June 9, 2015
Recall Summary
| Recall Number | Z-2454-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 9, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Omnilife Science Inc. |
| Location | East Taunton, MA |
| Product Type | Devices |
| Quantity | 15 |
Product Description
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
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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.
Lot / Code Information
Lot Numbers: MM0314R, VA0713, Z1111
Other Recalls from Omnilife Science Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0921-2021 | Class II | SERF Novae Dual Mobility Cup Insert 47/28- ApeX... | Dec 21, 2020 |
| Z-0920-2021 | Class II | SERF Novae Dual Mobility Cup Insert 51/28- ApeX... | Dec 21, 2020 |
| Z-0922-2021 | Class II | SERF Novae Dual Mobility Cup Insert 49/28-ApeX-... | Dec 21, 2020 |
| Z-0169-2020 | Class II | OMNI Hip System Model, Catalogue, or Order Num... | Sep 11, 2019 |
| Z-2481-2019 | Class II | OMNIlife science, Inc. ApeX acetabular liner ... | Jul 23, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.