Home › Avalign Technologies, Inc. › Millennium
Millennium
Avalign Technologies, Inc. · Model 1-SGM · UDI-DI 00190776164331
FZW
Prescription
8
510(k) clearances
5,240
Adverse events
9
Recalls
65
Facilities
Description
OHSU Customer Vaginoplasty Skin Graft Mold
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-02 | Zimmer Surgical Inc | Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft i |
| 2017-04-24 | Molnlycke Health Care, Inc | Sterilization validation failure. |
| 2010-01-29 | Linvatec Corp. dba ConMed Linvatec | There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage. |
| 2008-04-03 | Zimmer Inc. | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
| 2008-04-03 | Zimmer Inc. | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
| 2008-04-03 | Zimmer Inc. | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
| 2008-04-03 | Zimmer Inc. | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
| 2008-04-03 | Zimmer Inc. | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
| 2008-04-03 | Zimmer Inc. | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
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.