NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed...
FDA Device Recall #Z-1936-2014 — Class II — May 19, 2014
Recall Summary
| Recall Number | Z-1936-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 19, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | 41,180 total |
Product Description
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Reason for Recall
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
Lot / Code Information
Size 5, includes the following Lot numbers: 370318 37214652 61424997 61442318 61442319 61442320 61451223 61454955 61454956 61459968 61459969 61459970 61475130 61475131 61475132 61488234 61518182 61518183 61518184 61526402 61543977 61567344 61567345 61592091 61592092 61627258 61627260 61643935 61643936 61658884 61658885 61658886 61774178 61774179 61774180 61774181 61774182 61774183 61863148 61863149 61863150 61863151 61863152 61912439 61934688 61934689 61935101 61935102 61979031 61979032 61979033 62016160 62016162 62022559 62037894 62037895 62051524 62051525 62069546 62089014 62089015 62143608 62168185 62177112 62193308 62200281 62200282 62200283 62214674 62214675 62227420 62261968 62261972 62261973 62261975 62298570 62332566 62352641 62358491 62358492 62377651 62423843 62455679 62460240 62460242 62460243 62525441 62525442 62586581 62586582 62610910 62610911 62610912 62640982 62646149 62646150
Other Recalls from Zimmer, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0981-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0979-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0973-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0977-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0967-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
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.