Retention Device, Suture
General, Plastic Surgery · 21 CFR 878.4930
Recent MDR events
251 adverse event reports on file
- FLOWSTASIS DEVICEDec 30, 2025DeathInari Medical, Inc.MW5181422
- XTENDOBUTTON ROUND LG 21 DIA 10 PEGSep 21, 2025InjurySmith & Nephew, Inc.1219602-2025-02330
- XTENDOBUTTON FIXATION DEVICEJul 28, 2025MalfunctionSmith & Nephew, Inc.1219602-2025-01870
- UNKN SUSPENSORY FIXATION DEVMay 5, 2024InjurySmith & Nephew, Inc.1219602-2024-00937
- XTENDOBUTTON FIXATION DEVICEApr 9, 2024MalfunctionSmith & Nephew, Inc.1219602-2024-00739
- UNKN JOINT REPAIR DEVJul 14, 2023InjurySmith & Nephew, Inc.1219602-2023-01216
- UNKN JOINT REPAIR DEVJul 14, 2023InjurySmith & Nephew, Inc.1219602-2023-01218
- UNKN JOINT REPAIR DEVJul 14, 2023InjurySmith & Nephew, Inc.1219602-2023-01220
- UNKN JOINT REPAIR DEVJul 14, 2023InjurySmith & Nephew, Inc.1219602-2023-01222
- UNKN JOINT REPAIR DEVJul 14, 2023InjurySmith & Nephew, Inc.1219602-2023-01224
Event type breakdown
Recalls
2 recall events for this product code
- Drs Vascular, IncOpen, ClassifiedAug 15, 2025
Brand Name: Q-Stop
XXX
Z-2330-2025 · View FDA record ↗ - Smith & Nephew, Inc. Endoscopy DivisionTerminatedApr 26, 2006
FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair.
The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor.
Z-0798-06 · View FDA record ↗
Registered firms
94 firms currently registered for this product code
Riverpoint Medical Llc
Portland, OR, US
Microport Orthopedics Global Supply Center Limited
Shanghai, CN
Boston Medical Products, Inc.
Shrewsbury, MA, US
Smith & Nephew, Inc.
Memphis, TN, US
Conextions Inc
Salt Lake City, UT, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Inari Medical, Inc.
Irvine, CA, US
Demetech Corp.
Miami Lakes, FL, US
Synthes (usa) Products Llc
West Chester, PA, US
Ziptek Llc
Sarasota, FL, US
Isomedix Operations, Inc.
Temecula, CA, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Suturegard Medical, Inc.
Corvallis, OR, US
Implantech Associates, Inc.
Ventura, CA, US
Comfort Surgical Instruments
Sialkot Punjab, PK
Drs Vascular, Inc.
San Jose, CA, US
Merit Medical Asia Company Limited
Tsim Sha Tsui, HK
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Zimmer Pte. Ltd.
Singapore South East, SG
Zhejiang Mediunion Healthcare Group Co.,ltd
Ningbo Zhejiang, CN
Hi-tech Products De Mexico S.a. De C.v.
La Mesa, Tijuana Baja California, MX
Sterigenics U.s., Llc
Queensbury, NY, US
Zimmer Biomet Pty Ltd
Sydney New South Wales, AU
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Smith & Nephew Inc.
MANSFIELD, MA, US
510(k) clearances
20 clearances for this product code
- Accu-Speed, IncorporatedJan 28, 2003
K030031 · SOFT TISSUE ANCHORING WASHERS
- Smith & Nephew, Inc.Mar 12, 2002
K020480 · RBM
- Smith & Nephew Endoscopy, Inc.Feb 25, 1997
K964935 · SUTURE LOCK
- Acufex Microsurgical, Inc.Jun 30, 1995
K941740 · ACUFEX ROTATOR CUFF FIXATION BUTTON
- Mitek Surgical Products, Inc.Nov 9, 1993
K930675 · MITEK CONE WASHER
- Aesculap, Inc.Aug 29, 1991
K904435 · VENTROFIL TENSION RELIEF SUTURE SET
- The Hygenic Corp.Apr 17, 1991
K911225 · TRAY DOUGH
- Surgical Systems, Inc.Oct 2, 1990
K904136 · SUTURE TENSION ADJUSTMENT REEL