LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be ...
FDA Device Recall #Z-1241-2015 — Class II — February 3, 2015
Recall Summary
| Recall Number | Z-1241-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 3, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Howmedica Osteonics Corp. |
| Location | Mahwah, NJ |
| Product Type | Devices |
| Quantity | 9 units |
Product Description
LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.
Reason for Recall
Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion.
Distribution Pattern
Distributed in the states of GA, MA, NC, NY & PA.
Lot / Code Information
Lot Code 48681201
Other Recalls from Stryker Howmedica Osteonics Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2160-2017 | Class II | Hoffmann LRF Safety Clip (Bone Transport Strut)... | Apr 26, 2017 |
| Z-1020-2017 | Class II | Reunion TSA Peg Alignment Sound Catalog #5901... | Dec 2, 2016 |
| Z-0880-2017 | Class II | GAM Kirschner Wire, Sterile R, T2 K-Wire, Steri... | Nov 9, 2016 |
| Z-0378-2017 | Class II | LFIT Anatomic V40 Femoral Head, Low Friction Io... | Aug 29, 2016 |
| Z-0060-2017 | Class II | Stryker Orthopaedics Universal Acetabular Cup P... | Aug 18, 2016 |
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.