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GENESIS
Smith & Nephew, Inc. · Model 71243612 · UDI-DI 03596010504166
HSX
Prescription
1
510(k) clearances
2,520
Adverse events (1 deaths)
104
Recalls
154
Facilities
Description
GENISIS TIBIA POLY ONLAY MAGNUM LEFT MEDIAL/RIGHT LATERAL12MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-02 | Smith & Nephew, Inc. | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a poten |
| 2023-05-02 | Smith & Nephew, Inc. | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a poten |
| 2023-05-02 | Smith & Nephew, Inc. | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a poten |
| 2023-05-02 | Smith & Nephew, Inc. | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a poten |
| 2023-03-27 | Smith & Nephew, Inc. | A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tib |
| 2023-03-21 | Linkbio Corp. | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea |
| 2023-03-21 | Linkbio Corp. | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea |
| 2023-03-21 | Linkbio Corp. | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea |
| 2023-03-21 | Linkbio Corp. | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea |
| 2023-03-21 | Linkbio Corp. | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea |
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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.