Home › Ascension Orthopedics, Inc. › Ascension®
Ascension®
Ascension Orthopedics, Inc. · Model TRL50050 · UDI-DI 10381780236641
KYJ
Prescription
1
510(k) clearances
499
Adverse events
4
Recalls
19
Facilities
Description
The Silicone MCP Trial is used to evaluate component collar contact on osteotomy and stem fit in prepared cavities. The trial evaluates joint articulation and ligament tension.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.