Home › AROA BIOSURGERY LIMITED › Endoform™ Dental Membrane
Endoform™ Dental Membrane
AROA BIOSURGERY LIMITED · Model DE02NF004S · UDI-DI 09421907331706
NPL
Prescription
1
510(k) clearances
191
Adverse events
11
Recalls
55
Facilities
Description
Endoform™ Dental Membrane is an ovine derived bioabsorbable extracellular matrix intended for application in dental and periodontal procedures. The device is comprosed of non-cross linked and non-reconstituted collagen. The device is supplied sterile in a variety of sizes and thicknesses which may be trimmed by a licensed dentist or oral surgeon to meet individual patient needs.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-03-19 | Collagen Matrix, Inc. | Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box |
| 2016-12-02 | Biom'up | Lack of sterility assurance |
| 2012-02-28 | Kensey Nash Corp | Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in pa |
| 2012-02-28 | Kensey Nash Corp | Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in pa |
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.