Septal Stapler/absorbable Staples
General, Plastic Surgery · 21 CFR 878.4750
To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted. To connect internal nasal tissues to aid healing during nasal septum reconstruction.
Recent MDR events
25 adverse event reports on file
- ENTACT SEPTAL STAPLER 3-PACKJun 1, 2025MalfunctionArthrocare Corporation3006524618-2025-00269
- ENTACT SEPTAL STAPLER 3-PACKJan 20, 2025MalfunctionArthrocare Corporation3006524618-2025-00019
- ENTACT SEPTAL STAPLER 3-PACKMay 5, 2024MalfunctionArthrocare Corporation3006524618-2024-00169
- UNKN ACCESS DEVNov 29, 2022InjurySmith & Nephew, Inc.1219602-2022-01862
- ENTACT SEPTAL STAPLER 3-PACKMar 18, 2022InjuryArthrocare Corp.3006524618-2022-00095
- ENT SINUSFeb 4, 2020MalfunctionSmith & Nephew, Inc.9664356
- ENTACT SEPTAL STAPLER 3-PACKDec 26, 2019MalfunctionArthrocare Corp.3006524618-2019-00617
- ENTACT SEPTAL STAPLER 3-PACKDec 26, 2019MalfunctionArthrocare Corp.3006524618-2019-00618
- ENTACT SEPTAL STAPLER, 3-PACKOct 29, 2018InjuryArthrocare Corp.3006524618-2018-00569
- ENTACT SEPTAL STAPLER, 1-PACKSEPTAL STAPLER/ABSORBABLE STAPLESAug 7, 2018MalfunctionArthrocare Corporation3006524618-2018-00400
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
Sterigenics Us Llc
Fort Worth, TX, US
Sterigenics Us Llc
Gurnee, IL, US
Sterigenics Us Llc
Los Angeles, CA, US
Sterigenics U.s., Llc
Corona, CA, US
Cea Global Dominicana D.b.a. Nissha Medical Technologies
San Pedro de Macoris, DO
Sterigenics Us Llc
Charlotte, NC, US
Arthrocare Corporation
Austin, TX, US
Smith & Nephew Inc.
OKLAHOMA CITY, OK, US
510(k) clearances
1 clearances for this product code