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Silicone MCP
Smith & Nephew, Inc. · Model SMCP-500-30-WW · UDI-DI 00885556856901
KYJ
Prescription
2
510(k) clearances
494
Adverse events
4
Recalls
19
Facilities
Description
Silicone MCP Sz 30
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-18 | Osteotec Limited | There is the potential that the silicone implant may contain foreign material |
| 2019-11-04 | Integra Lifesciences Sales Llc | Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant |
| 2016-11-08 | Wright Medical Technology, Inc. | The firm discovered a lack of adequate documentation confirming sterility on certain products. |
| 2016-11-08 | Wright Medical Technology, Inc. | The firm discovered a lack of adequate documentation confirming sterility on certain products. |
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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.