Suture, Nonabsorbable, Synthetic, Polyethylene
FDA product code GAT · Class II (moderate risk) · 21 CFR 878.5000 · General, Plastic Surgery
176510(k) clearances
0PMA approvals
22recalls
Implantimplanted device
Manufacturers
- Arthrex, Inc. 19
- Smith & Nephew, Inc. 11
- Teleflex Medical 9
- Riverpoint Medical, LLC 7
- Threadstone, LLC 5
- Medos International SARL 5
- Usgi Medical 4
- Anulex Technologies, Inc. 4
- Sentreheart, Inc. 4
- Teleflexmedical, Inc. 4
- Neotract, Inc. 3
- Cp Medical 3
- Musculoskeletal Transplant Foundation 3
- United States Surgical, A Division of Tyco Healthc 3
- Axya Medical 3
- Cayenne Medical, Inc. 3
- Ceterix Orthopaedics, Inc. 3
- Aesculap, Inc. 2
- Sutures , Ltd. 2
- GM Dos Reis Industria e Comercio Ltda. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253910 | Stitch - Suture Wires and TapesGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/22/2026SE |
| K261021 | EasyWhip FamilyGAT · Traditional | Winter Innovations, Inc. | 07/01/2026SE |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | Teleflex Medical, LLC | 05/06/2026SE |
| K254275 | HyperSuture All Green Extension LineGAT · Traditional | Threadstone, LLC | 03/23/2026SE |
| K254188 | Meniscus VersaflexGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 02/19/2026SE |
| K253145 | Pre-Sutured TendonGAT · Special | Rti Surgical, Inc. | 10/22/2025SE |
| K253024 | ProZip Knotless ImplantGAT · Special | Riverpoint Medical | 10/16/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | Medacta International S.A. | 09/12/2025SE |
| K252201 | HS FiberGAT · Special | Riverpoint Medical | 08/13/2025SE |
| K242201 | HyperSuture White/Green Extension LineGAT · Traditional | Threadstone, LLC | 03/27/2025SE |
| K241376 | HyperSuture All Blue Extension LineGAT · Traditional | Threadstone, LLC | 08/09/2024SE |
| K234079 | HyperSuture Extension LineGAT · Traditional | Threadstone, LLC | 05/10/2024SE |
| K231163 | HS Fiber SuturesGAT · Traditional | Riverpoint Medical | 01/05/2024SE |
| K230311 | HyperSutureGAT · Traditional | Threadstone, LLC | 11/24/2023SE |
| K231183 | Non absorbable Surgical Polyester SutureGAT · Traditional | Shandong Haidike Medical Products Co., Ltd. | 08/25/2023SE |
| K223500 | SuperBall Meniscal Repair SystemGAT · Traditional | Arcuro Medical , Ltd. | 08/10/2023SE |
| K223122 | Menix®; Menix® DuoGAT · Traditional | S.B.M. Sas (Science & Bio Materials) | 08/03/2023SE |
| K230510 | MyEllevateGAT · Traditional | Cynosure, LLC | 07/06/2023SE |
| K213046 | AceConnex Pre-Sutured FasciaGAT · Traditional | Allosource | 06/27/2023SE |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple…GAT · Traditional | Rti Surgical, Inc. | 06/23/2023SE |
| K223822 | ActivbraidGAT · Traditional | Embody, Inc. | 06/02/2023SE |
| K220880 | Arthrex BioSutureGAT · Special | Arthrex, Inc. | 10/27/2022SE |
| K222078 | Arthrex SoftStitchGAT · Traditional | Arthrex, Inc. | 09/14/2022SE |
| K221354 | Arthrex SutureTapeGAT · Special | Arthrex, Inc. | 09/09/2022SE |
| K220186 | Zone Specific AIMGAT · Traditional | Conmed Corporation | 05/13/2022SE |
| K220219 | PERMALOOP Suture, PERMATAPE SutureGAT · Traditional | Medos International SARL | 04/26/2022SE |
| K212146 | Arthrex LoopLoc Knotless SutureGAT · Traditional | Arthrex, Inc. | 10/25/2021SE |
| K210675 | EasyWhipGAT · Traditional | Winter Innovations, Inc. | 05/03/2021SE |
| K203186 | DYNATAPE SutureGAT · Traditional | Medos International SARL | 03/18/2021SE |
| K203393 | Fast-Fix FlexGAT · Traditional | Smith & Nephew, Inc. | 02/01/2021SE |
| K190707 | Arthrex SoftStitchGAT · Traditional | Arthrex, Inc. | 10/02/2020SE |
| K202242 | HS FiberGAT · Special | Riverpoint Medical, LLC | 09/10/2020SE |
| K193575 | Arthrex SutureTapeGAT · Traditional | Arthrex, Inc. | 07/24/2020SE |
| K192490 | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchGAT · Traditional | Teleflex Medical | 03/30/2020SE |
| K192637 | High Strength SutureGAT · Traditional | Yunyi (Beijing) Medical Device Co., Ltd. | 03/02/2020SE |
| K190777 | DemeTECH DemeFORCE Nonabsorbable Surgical SutureGAT · Traditional | Demetech Corporation | 07/31/2019SE |
| K191268 | Force Fiber SutureGAT · Special | Teleflex Medical Incorporated | 06/11/2019SE |
| K190817 | HS FiberGAT · Special | Riverpoint Medical | 05/01/2019SE |
| K181633 | MTF Pre-Sutured TendonGAT · Traditional | Musculoskeletal Transplant Foundation | 03/15/2019SE |
| K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…GAT · Traditional | Teleflex Medical Incorporated | 10/10/2018SE |
| K181182 | DYNACORD SutureGAT · Traditional | Medos International SARL | 08/02/2018SE |
| K181772 | NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)GAT · Special | Ceterix Orthopaedics, Inc. | 08/01/2018SE |
| K180191 | SuperBall Meniscal Repair SystemGAT · Traditional | Arcuro Medical , Ltd. | 06/05/2018SE |
| K180531 | NovoStitch Pro Meniscal Repair SystemGAT · Special | Ceterix Orthopaedics, Inc. | 03/29/2018SE |
| K170957 | ReConnex Pre-Sutured TendonGAT · Traditional | Allosource | 03/20/2018SE |
| K172016 | Force Fiber Fusion SutureGAT · Traditional | Teleflex Medical Incorporated | 10/03/2017SE |
| K170642 | GRAVITY Soft Tissue Repair SystemGAT · Traditional | Wrightmedicaltechnologyinc | 08/22/2017SE |
| K171680 | Infinity-Lock 3, Infinity-Lock 5GAT · Special | Xiros, Ltd. | 06/30/2017SE |
| K171296 | SutureTapeGAT · Special | Arthrex, Inc. | 05/26/2017SE |
| K163651 | ExpressBraid Graft ManipulationGAT · Traditional | Biomet Manufacturing Corp | 02/17/2017SE |
| K163142 | SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid…GAT · Special | ArthroCare Corporation | 01/06/2017SE |
| K160854 | MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureGAT · Traditional | Biomet Manafacturing Corp. | 12/19/2016SE |
| K162247 | PermatapeGAT · Traditional | Medos International SARL | 12/15/2016SE |
| K162310 | XBraid TT Suture TapeGAT · Traditional | Stryker | 11/10/2016SE |
| K161638 | SPEEDTRAP Graft Preparation SystemGAT · Traditional | Medos International SARL | 11/07/2016SE |
| K153089 | 'cottony' II TAPE, PLEDGETSGAT · Traditional | Teleflexmedical, Inc. | 08/12/2016SE |
| K153087 | IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus…GAT · Traditional | Ivy Sports Medicine, LLC | 07/14/2016SE |
| K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…GAT · Traditional | Teleflexmedical, Inc. | 06/16/2016SE |
| K153746 | Dunamis Force DFX Tensile TapeGAT · Traditional | Dunamis, LLC | 03/03/2016SE |
| K153307 | HS SutureTapeGAT · Special | Riverpoint Medical | 02/12/2016SE |
| K152868 | ExpressBraid Graft ManipulationGAT · Traditional | Biomet Manufacturing Corp | 02/08/2016SE |
| K153096 | LARIAT RS Suture Delivery DeviceGAT · Special | Sentreheart, Inc. | 11/25/2015SE |
| K151758 | ALAR Nasal Valve StentGAT · Traditional | Medtronic Xomed, Inc. | 10/29/2015SE |
| K151009 | Nexus SutureGAT · Traditional | Baylis Medical Company, Inc. | 08/18/2015SE |
| K150584 | Stryker Suture TapeGAT · Traditional | Stryker | 08/13/2015SE |
| K143356 | NovoStitch Plus Meniscal Repair SystemGAT · Traditional | Ceterix Orthopaedics, Inc. | 07/21/2015SE |
| K150327 | Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2GAT · Traditional | Dunamis, LLC | 06/29/2015SE |
| K150438 | Force Fiber OrthoTape sutureGAT · Special | Teleflexmedical, Inc. | 04/02/2015SE |
| K142241 | LARIAT sulture Delivery DeviceGAT · Special | Sentreheart, Inc. | 09/12/2014SE |
| K141072 | SupoleneGAT · Traditional | Resorba Medical GmbH | 06/23/2014SE |
| K133770 | A.I.M. Knotless Meniscal Repair DeviceGAT · Traditional | Anchor Innovation Medical (A.I.M.) | 06/10/2014SE |
| K140019 | Arthrex BiosutureGAT · Special | Arthrex, Inc. | 01/30/2014SE |
| K132079 | TFCC Fast-Fix KitGAT · Traditional | Smith & Nephew, Inc. | 12/05/2013SE |
| K132357 | Smith & Nephew UltratapeGAT · Special | Smith & Nephew, Inc. | 10/30/2013SE |
| K132043 | Arthrex SpeedcinchGAT · Special | Arthrex, Inc. | 07/31/2013SE |
| K122735 | Sorin Vasculoop Two Tie Endoscopic Ligation System Model DTTS2GAT · Traditional | Sorin Group USA, Inc. | 05/21/2013SE |
| K123268 | Smartstitch Perfectpasser SystemGAT · Special | Arthocare Corporation | 11/07/2012SE |
| K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…GAT · Traditional | Smith & Nephew, Inc. | 10/18/2012SE |
| K122374 | Arthrex Suture (Uhmwpe)GAT · Special | Arthrex, Inc. | 09/25/2012SE |
| K121306 | Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device…GAT · Traditional | Arthocare Corporation | 07/12/2012SE |
| K121413 | Crossfix II Memiscal Repair DeviceGAT · Special | Cayenne Medical, Inc. | 06/04/2012SE |
| K112899 | Arthrex Bio-SutureGAT · Traditional | Arthrex, Inc. | 04/06/2012SE |
| K101377 | Smith & Newphew Ultrabraid II SutureGAT · Traditional | Smith & Newphew, Inc. | 04/08/2011SE |
| K102339 | Conmed Linvatec Sequent Meniscal Repair DeviceGAT · Traditional | Conmed Linvatec | 11/23/2010SE |
| K103052 | V-Loc(Tm) Nonabsorbable Wound Closure DeviceGAT · Traditional | Covidien, LLC | 11/10/2010SE |
| K102916 | G-Cath Tissue Anchor Delivery CatheterGAT · Special | Usgi Medical | 10/20/2010SE |
| K102028 | Neotract Anchor System Model TAS400GAT · Special | Neotract, Inc. | 08/04/2010SE |
| K101252 | Neotract Anchor System Model: Ref 11208GAT · Traditional | Neotract, Inc. | 07/15/2010SE |
| K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…GAT · Abbreviated | Riverpoint Medical | 05/10/2010SE |
| K094028 | Cp-Fiber (Orthofiber)GAT · Abbreviated | Cp Medical | 03/18/2010SE |
| K100572 | Versaclose, Model VC-200-01GAT · Special | Anulex Technologies, Inc. | 03/17/2010SE |
| K100506 | Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures…GAT · Special | Teleflex Medical | 03/10/2010SE |
| K100251 | G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333GAT · Special | Usgi Medical | 02/17/2010SE |
| K092508 | Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB…GAT · Traditional | Smith & Nephew, Inc. | 01/28/2010SE |
| K091061 | Implicitguide Surgical Suture SystemGAT · Traditional | Implicitcare, LLC | 11/13/2009SE |
| K091574 | Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and Black Surgical SuturesGAT · Abbreviated | Supplidores Unidos Internacionales, S.A. | 10/09/2009SE |
| K093018 | G-Prox Endoscopic Grasper, Model 205333GAT · Special | Usgi Medical | 10/07/2009SE |
| K092533 | Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesGAT · Special | Beere Precision Medical Instruments, Kmedic, Telef | 09/15/2009SE |
| K091432 | Xclose Tissue Repair System, Model XC-200-01GAT · Special | Anulex Technologies, Inc. | 06/12/2009SE |
| K090385 | Lariat II Suture Delivery DeviceGAT · Traditional | Sentreheart, Inc. | 05/06/2009SE |
| K091016 | Covidien Sports Surgery AS Meniscal Repair Device with High Strength SutureGAT · Special | Surgical Devices, A Global Business Unit Covidien | 05/04/2009SE |
| K090128 | Tac-Tite (TM)GAT · Special | Core Essence Orthopaedics, Inc. | 03/19/2009SE |
| K082518 | Dual Needle Suture Passer SystemGAT · Traditional | Cayenne Medical, Inc. | 01/16/2009SE |
| K082535 | Covidien Sports Surgery AS Meniscal Repair DeviceGAT · Traditional | Surgical Devices, A Global Business Unit Covidien | 12/01/2008SE |
| K073149 | Meniscal CinchGAT · Traditional | Arthrex, Inc. | 02/11/2008SE |
| K073096 | Anchorage Closure DeviceGAT · Traditional | Epitek, Inc. | 02/07/2008SE |
| K073651 | Neotract Anchor SystemGAT · Traditional | Neotract, Inc. | 02/01/2008SE |
| K071796 | Capsew Plication SystemGAT · Traditional | Cayenne Medical, Inc. | 10/19/2007SE |
| K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsGAT · Special | Smith & Nephew, Inc. | 09/18/2007SE |
| K070253 | Axya Suture Welding System and KitGAT · Traditional | Axya Medical, Inc. | 07/11/2007SE |
| K071622 | Arthrex FiberwireGAT · Special | Arthrex, Inc. | 07/03/2007SE |
| K070673 | Force Fiber Black Co-Braid Polyethylene Non-Absorbable Surgical SutureGAT · Special | Teleflexmedical, Inc. | 04/02/2007SE |
| K063778 | Force Fiber Polyethylene Nonabsorbable SutureGAT · Abbreviated | Teleflex Medical | 02/09/2007SE |
| K061276 | G-Prox Endoscopic GrasperGAT · Traditional | Usgi Medical | 12/06/2006SE |
| K063194 | Tufflex Polyester SutureGAT · Special | Axya Medical, Inc. | 12/04/2006SE |
| K060163 | Cardioflon, CardioxylGAT · Special | Peters Surgical | 10/11/2006SE |
| K062307 | Xclose Tissue Repair System, Model SRSGAT · Special | Anulex Technologies, Inc. | 09/01/2006SE |
| K060165 | Axyaflex Polyester SutureGAT · Traditional | Axya Medical, Inc. | 09/01/2006SE |
| K060367 | TenoligGAT · Traditional | Fournitures Hospitalieres Industrie | 08/09/2006SE |
| K061386 | Anchor Band Suturing System, Model Sr-AbGAT · Traditional | Anulex Technologies, Inc. | 07/05/2006SE |
| K060721 | Lariat Loop ApplicatorGAT · Traditional | Sentreheart | 06/02/2006SE |
| K053339 | Allofix AnchorGAT · Traditional | Musculoskeletal Transplant Foundation | 03/16/2006SE |
| K050150 | Mani Needle & Suture PackGAT · Traditional | Mani, Inc. | 12/05/2005SE |
| K052652 | Smith & Nephew Continuous Loop Fixation DeviceGAT · Traditional | Smith & Nephew, Inc. | 10/21/2005SE |
| K041512 | Nonabsorbable (Polyethylene Terephthalate) Surgical SutureGAT · Traditional | Sutures India Private Limited | 06/02/2005SE |
| K042038 | MTF Allograft AnchorGAT · Traditional | Musculoskeletal Transplant Foundation | 12/23/2004SE |
| K041553 | Arthrex Suture Grafting KitGAT · Traditional | Arthrex, Inc. | 12/10/2004SE |
| K042286 | Uniester CGAT · Traditional | United Medical Industries Co. , Ltd. | 12/01/2004SE |
| K042031 | Opus Speedstitch Suture DeviceGAT · Traditional | Opus Medical, Inc. | 10/19/2004SE |
| K041894 | OrthofiberGAT · Special | Cp Medical | 09/17/2004SE |
| K041589 | Arthrex Fiberwire with SilkGAT · Traditional | Arthrex, Inc. | 08/05/2004SE |
| K041216 | Smith & Nephew Ultrabraid SutureGAT · Abbreviated | Smith & Nephew, Inc. | 06/07/2004SE |
| K040789 | Durabraid SutureGAT · Abbreviated | Smith & Nephew, Inc. | 06/04/2004SE |
| K040472 | Force Fiber Blue Co-Braided Polyethylene Nonabsorbable Surgical SutureGAT · Special | Teleflex Medical | 03/15/2004SE |
| K040232 | Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model…GAT · Special | Lsi Solutions | 03/01/2004SE |
| K033718 | Maxbraid Polyester Plus and Polyethylene Plus SutureGAT · Traditional | Arthrotek, Inc. | 02/12/2004SE |
| K033654 | Force FiberGAT · Traditional | Teleflex Medical | 01/15/2004SE |
| K032245 | Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM…GAT · Traditional | Arthrex, Inc. | 01/14/2004SESU |
| K032901 | Stryker Mini-Mender Meniscal Repair SystemGAT · Abbreviated | Stryker Endoscopy | 12/02/2003SE |
| K023030 | Demetech Polyester Nonabsorbable SutureGAT · Traditional | Demetech Corp. | 06/18/2003SE |
| K021434 | Arthrex Fiberwire in Usp SizesGAT · Traditional | Arthrex, Inc. | 11/07/2002SE |
| K022410 | Saph-Loop Ligating LoopGAT · Special | Genzyme Biosurgery | 08/20/2002SE |
| K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester SutureGAT · Traditional | Genzyme Corp. | 06/18/2002SE |
| K020902 | SerralesterGAT · Traditional | Serral, S.A. DE C.V. | 05/20/2002SE |
| K013990 | Lifestitch Suturing DeviceGAT · Traditional | Edwards Lifesciences, LLC | 02/27/2002SE |
| K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201GAT · Traditional | Arthrex, Inc. | 10/04/2001SE |
| K012201 | Premicron Nonabsorbable PET Surgical SutureGAT · Traditional | Aesculap, Inc. | 09/19/2001SE |
| K002172 | Poly-Tapes (Various Sizes and Woven Construction Variants)GAT · Traditional | Xiros Plc | 08/28/2001SE |
| K010673 | Arthrex Fiberwire, Model SPU-02NB-3800GAT · Traditional | Arthrex, Inc. | 05/14/2001SE |
| K003590 | Grams Polyester Nonabsorbable SutureGAT · Traditional | Gramsmed, LLC | 03/05/2001SE |
| K001440 | Nextstitch Cardiovascular Valve SutureGAT · Traditional | Genzyme Surgical Product (Genzyme Biosurgery) | 11/13/2000SE |
| K001172 | Polyester Nonabsorbable Surgical Sutures UrpGAT · Traditional | Cp Medical | 06/23/2000SN |
| K001434 | 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical SutureGAT · Traditional | Genzyme Surgical Product (Genzyme Biosurgery) | 06/12/2000SN |
| K000540 | Polyester Nonabsorbable Surgical Sutures, UspGAT · Traditional | Arc Medical Supplies (Beijing) Co, Ltd. | 04/27/2000SN |
| K994000 | PolyesterGAT · Traditional | Trading Consultants and Distributors Intl., Inc. | 02/04/2000SE |
| K990952 | Novafil** and Vascufil** Sterile Synthetic Non-Absorbable SuturesGAT · Traditional | United States Surgical, A Division of Tyco Healthc | 04/01/1999SE |
| K984550 | Pre-Threaded EndobuttonGAT · Traditional | Smith & Nephew, Inc. | 03/01/1999SE |
| K990088 | Synthofil Nonabsorbable PET Surgical SutureGAT · Traditional | Aesculap, Inc. | 02/10/1999SE |
| K972911 | Auto Suture*Endostitch* Ii** Suture ApplierGAT · Traditional | United States Surgical, A Division of Tyco Healthc | 04/25/1998SE |
| K980155 | Endobutton Continuous LoopGAT · Traditional | Smith & Nephew, Inc. | 04/01/1998SE |
| K970416 | Acufex Double Armed Suture NeedleGAT · Traditional | Smith & Nephew Endoscopy, Inc. | 04/21/1997SE |
| K961925 | Polyester Nonabsorbable Surgical Sutures UspGAT · Traditional | R. K. Medical L. L. C. | 07/29/1996SN |
| K961025 | Expanded Body SutureGAT · Traditional | Medicinelodge, Inc. | 04/15/1996SN |
| K955747 | Ussc Nonabsorbable SuturesGAT · Traditional | United States Surgical, A Division of Tyco Healthc | 02/27/1996SN |
| K952535 | Acufex Endobutton TapeGAT · Traditional | Acufex Microsurgical, Inc. | 02/08/1996SN |
| K943221 | SurgibondGAT · Traditional | Sutures , Ltd. | 12/05/1994SN |
| K943220 | SutuleneGAT · Traditional | Sutures , Ltd. | 12/05/1994SN |
| K943949 | Polyviolene Surgicl SutureGAT · Traditional | Look, Inc. | 11/10/1994SN |
| K931916 | Suture Non-Absorbable Synthetic PolyesterGAT · Traditional | Surgimetrics International, Ltd. | 03/03/1994SE |
| K932038 | Suture Nonabsorbable- Silk, PolyesterGAT · Traditional | Surgical Specialties, Inc. | 01/07/1994SE |
| K930945 | Braided Polyester Surgical SutureGAT · Traditional | Lukens Medical Corp. | 12/17/1993SE |
| K930942 | Lukens Silk Surgical SutureGAT · Traditional | Lukens Medical Corp. | 12/17/1993SE |
| K930591 | Ti-Cron and Dacron SuturesGAT · Traditional | Davis & Geck, Inc. | 12/17/1993SE |
| K930590 | Silk SuturesGAT · Traditional | Davis & Geck, Inc. | 12/17/1993SE |
| K926167 | Polyviolene Suture-Revised LabelingGAT · Traditional | Look, Inc. | 12/17/1993SE |
| K920421 | Medsurg Marshmallow TrayGAT · Traditional | Medsurg Industries, Inc. | 12/13/1993SESK |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1182-2023 Class II | Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | Covidien, LP | 12/02/2022Open, Classified |
| Z-1181-2023 Class II | Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | Covidien, LP | 12/02/2022Open, Classified |
| Z-1177-2023 Class II | Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | Covidien, LP | 12/02/2022Open, Classified |
| Z-1175-2023 Class II | Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | Covidien, LP | 12/02/2022Open, Classified |
| Z-2548-2019 Class II | QuickGraft Model # 430PSTMeasurement listed on the label is not taken under tension, and this would cause possible extension of… | Musculoskeletal Transplant Foundation, Inc. | 08/15/2019Terminated |
| Z-3000-2020 Class II | Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI:…The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw… | ArthroCare Corporation | 02/21/2019Terminated |
| Z-1822-2015 Class II | ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal…Sterility of device maybe compromised | Smith & Nephew, Inc. | 04/30/2015Terminated |
| Z-2676-2014 Class II | The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of…A potential splitting of the surface treatment of the thread ends on certain sutures has recently been… | Peters Surgical | 06/25/2014Terminated |
| Z-2675-2014 Class II | The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester…A potential splitting of the surface treatment of the thread ends on certain sutures has recently been… | Peters Surgical | 06/25/2014Terminated |
| Z-1559-2014 Class II | Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | Teleflex Medical | 03/11/2014Terminated |
| Z-1556-2014 Class II | Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | Teleflex Medical | 03/11/2014Terminated |
| Z-1296-2014 Class II | Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable…The products are being recalled because they did not meet minimum needle attachment strength requirements. | Teleflex Medical | 03/11/2014Terminated |
| Z-1295-2014 Class II | Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only…The products are being recalled because they did not meet minimum needle attachment strength requirements. | Teleflex Medical | 03/11/2014Terminated |
| Z-1294-2014 Class II | Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage:…The products are being recalled because they did not meet minimum needle attachment strength requirements. | Teleflex Medical | 03/11/2014Terminated |
| Z-1293-2014 Class II | Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage:…The products are being recalled because they did not meet minimum needle attachment strength requirements. | Teleflex Medical | 03/11/2014Terminated |
| Z-1292-2014 Class II | Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage:…The products are being recalled because they did not meet minimum needle attachment strength requirements. | Teleflex Medical | 03/11/2014Terminated |
| Z-1291-2014 Class II | Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage:…The products are being recalled because they did not meet minimum needle attachment strength requirements. | Teleflex Medical | 03/11/2014Terminated |
| Z-0611-2012 | OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation…Product is being removed from the field due to an over-label issue. | Innovatech Medical Resources L.P. | 08/08/2011Terminated |
| Z-0421-2011 | Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE Catalog Number; 72202469. Intended…FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. | Smith & Nephew, Inc. Endoscopy Division | 10/14/2010Terminated |
| Z-0420-2011 | Smith & Nephew FAST FIX 360, CURVED NEEDLE Catalog Number; 72202468. Intended for use as…FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. | Smith & Nephew, Inc. Endoscopy Division | 10/14/2010Terminated |
| Z-0419-2011 | Smith & Nephew FAST FIX 360, STRAIGHT NEEDLE Catalog Number; 72202467. Intended for use…FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. | Smith & Nephew, Inc. Endoscopy Division | 10/14/2010Terminated |
| Z-0807-2007 | Product is an EO Sterile, Polyester braided and coated nonabsorbable surgical suture…Potential for sterility of product to be compromised. Suture package seals incomplete or missing. | C P Medical | 04/03/2007Terminated |