Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer se...
FDA Device Recall #Z-2292-2016 — Class II — June 30, 2016
Recall Summary
| Recall Number | Z-2292-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 30, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer Gmbh |
| Location | Winterthur, N/A |
| Product Type | Devices |
| Quantity | 2 |
Product Description
Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). " Acute traumatic fracture of the femoral head or neck " Avascular necrosis of the femoral head. " Avenir Moller Stems are for cementless use only.
Reason for Recall
Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging of the Avenir M¿ller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision.
Distribution Pattern
Nationwide Distribution to OH and NM
Lot / Code Information
Item Name: Avenir M¿ller Stem 4 Standard Item Number: 01.06010.004 Lot Number: 4022860 Item Name: Avenir M¿ller Stem 6 Lateral Item Number: 01.06010.106 Lot Number: 4023094
Other Recalls from Zimmer Gmbh
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3132-2024 | Class II | Biolox Option Taper Sleeve, Type 1 Taper, Stand... | Aug 8, 2024 |
| Z-3133-2024 | Class II | Biolox Option Taper Sleeve, Type 1 Taper, -6mm ... | Aug 8, 2024 |
| Z-1793-2021 | Class II | Zimmer Natural Nail- ZNN Cephalomedullary Short... | May 7, 2021 |
| Z-1792-2021 | Class II | Zimmer Natural Nail -ZNN Cephalomedullary Short... | May 7, 2021 |
| Z-2762-2019 | Class II | Sidus Stem-Free Shoulder Humeral Head 50-18 It... | Aug 21, 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.