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NexGen® Legacy®
Zimmer, Inc. · Model 5960-16-51 · UDI-DI 00889024001039
2
510(k) clearances
25,951
Adverse events (7 deaths)
269
Recalls
37
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-08-10 | DePuy Orthopaedics, Inc. | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau |
| 2021-08-10 | DePuy Orthopaedics, Inc. | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau |
| 2021-08-10 | DePuy Orthopaedics, Inc. | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau |
| 2021-08-10 | DePuy Orthopaedics, Inc. | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau |
| 2021-08-10 | DePuy Orthopaedics, Inc. | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau |
| 2021-08-10 | DePuy Orthopaedics, Inc. | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau |
| 2021-08-10 | DePuy Orthopaedics, Inc. | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau |
| 2021-02-22 | DePuy Orthopaedics, Inc. | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Ar |
| 2021-02-22 | DePuy Orthopaedics, Inc. | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Ar |
| 2019-10-10 | Zimmer Biomet, Inc. | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.