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.