Suture, Absorbable, Synthetic, Polyglycolic Acid
FDA product code GAM · Class II (moderate risk) · 21 CFR 878.4493 · General, Plastic Surgery
149510(k) clearances
0PMA approvals
128recalls
Implantimplanted device
Manufacturers
- ETHICON, Inc. 27
- United States Surgical, A Division of Tyco Healthc 12
- Surgical Specialties Corp 8
- Aesculap, Inc. 7
- Foosin Medical Supplies Inc., Ltd. 5
- Davis & Geck, Inc. 4
- Origami Surgical, LLC 4
- Coapt Systems, Inc. 4
- United Medical Industries Co. , Ltd. 4
- Teleflex Medical 3
- Demetech Corp. 3
- Internacional Farmaceutica, S.A. DE C.V. 3
- Depuy Mitek, A Johnson & Johnson Company 3
- Peters Surgical 3
- Cp Medical 3
- Gordian Surgical, Ltd. 3
- Surgical Specialties Corp. Dba Angiotech 3
- Silhouette Lift, Inc. 3
- Sm Eng Co., Ltd. 3
- Surgical Devices, Tyco Healthcare Group LP 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253394 | Coated VICRYL (Polyglactin 910) Plus Antibacterial SutureGAM · Traditional | ETHICON, Inc. | 06/25/2026SE |
| K253530 | Trexon Monofilament Synthetic Absorbable SutureGAM · Traditional | Medtronic | 05/28/2026SE |
| K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic…GAM · Traditional | ETHICON, Inc. | 02/06/2026SE |
| K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL…GAM · Traditional | ETHICON, Inc. | 12/22/2025SE |
| K253620 | TroClose 1200GAM · Special | Gordian Surgical, Ltd. | 12/16/2025SE |
| K252820 | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90…GAM · Special | Internacional Farmacéutica S.A DE C.V | 10/03/2025SE |
| K233265 | Monotime and Optime RGAM · Abbreviated | Peters Surgical | 10/11/2024SE |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)GAM · Abbreviated | Peters Surgical | 07/12/2024SE |
| K221527 | StitchKitGAM · Traditional | Origami Surgical Inc . | 02/14/2023SE |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceGAM · Traditional | ETHICON, Inc. | 11/15/2022SE |
| K212810 | MONOFIX PGCL, knotless wound closure deviceGAM · Traditional | Samyang Holdings Corp., Ltd. | 08/05/2022SE |
| K211792 | StitchKitGAM · Special | Origami Surgical Inc . | 07/16/2021SE |
| K202950 | StitchKit COMBOGAM · Traditional | Origami Surgical | 02/23/2021SE |
| K201996 | Monocryl Plus Antibacterial SutureGAM · Traditional | ETHICON, Inc. | 12/21/2020SE |
| K200392 | RexsinGAM · Traditional | Sm Eng Co., Ltd. | 07/07/2020SE |
| K200140 | Silhouette InstaliftGAM · Traditional | Silhouette Lift, Inc. | 03/27/2020SE |
| K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceGAM · Traditional | ETHICON, Inc. | 12/18/2019SE |
| K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II…GAM · Traditional | ETHICON, Inc. | 06/27/2019SE |
| K183004 | Wego-Pga RapidGAM · Traditional | Foosin Medical Supplies Inc., Ltd. | 01/28/2019SE |
| K183001 | Wego-Pgla RapidGAM · Traditional | Foosin Medical Supplies Inc., Ltd. | 01/28/2019SE |
| K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable SutureGAM · Traditional | ETHICON, Inc. | 09/28/2018SE |
| K181320 | CaprolonGAM · Traditional | Resorba Medical GmbH | 09/18/2018SE |
| K180625 | Rondek PGA Suture (Beige or Violet)GAM · Traditional | Rk Manufacturing Corporation | 05/10/2018SE |
| K173874 | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOGAM · Traditional | Origami Surgical, LLC | 05/04/2018SE |
| K173779 | Rexmono, PdrexGAM · Traditional | Sm Eng Co., Ltd. | 03/12/2018SE |
| K173043 | Holycon Synthetic Absorbable SuturesGAM · Traditional | Nantong Holycon Medical Devices Co., Ltd. | 12/14/2017SE |
| K171001 | Monosyn Quick Synthetic Absorbable Surgical SutureGAM · Traditional | Aesculap, Inc. | 10/23/2017SE |
| K170166 | CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing)…GAM · Traditional | Cpt Sutures Co., Ltd. | 09/29/2017SE |
| K172659 | MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable…GAM · Special | M/s. Meril Endo Surgery Private Limited. | 09/28/2017SE |
| K163676 | Silhouette InstaLiftGAM · Traditional | Silhouette Lift, Inc. | 06/16/2017SE |
| K171494 | TroClose1200, TroClose1200 CannulaGAM · Special | Gordian Surgical, Ltd. | 06/15/2017SE |
| K170661 | Novosyn Quick Absorbable SutureGAM · Traditional | Aesculap, Inc. | 06/08/2017SE |
| K161629 | CrylrexGAM · Traditional | Sm Eng Co., Ltd. | 02/10/2017SE |
| K160564 | TroClose1200GAM · Traditional | Gordian Surgical, Ltd. | 11/17/2016SE |
| K161726 | E-Pack Procedure KitGAM · Special | ETHICON, Inc. | 07/12/2016SE |
| K153611 | Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND…GAM · Traditional | Ethicon, LLC | 06/03/2016SE |
| K143584 | Pga Resorba, Pga Resoquick, GlycolonGAM · Traditional | Resorba Medical GmbH | 11/02/2015SE |
| K150717 | Megasorb, Mitsu, Mitsu FST, Filaxyn, FilapronGAM · Traditional | M/s. Meril Endo Surgery Private Limited. | 10/14/2015SE |
| K151200 | STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus…GAM · Traditional | ETHICON, Inc. | 08/13/2015SE |
| K142061 | Silhouette InstaliftGAM · Traditional | Silhouette Lift, Inc. | 04/24/2015SE |
| K142822 | PLIASURE Polyglycolide Synthetic Absorbable SutureGAM · Traditional | ETHICON, Inc. | 03/26/2015SE |
| K142810 | WEGO-PGCL Absorbable Surgical Monofilament SutureGAM · Special | Foosin Medical Supplies Inc., Ltd. | 11/14/2014SE |
| K140039 | PolycrylGAM · Traditional | Aurolab | 09/15/2014SE |
| K141778 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignGAM · Special | Surgical Specialties Corporation | 07/30/2014SE |
| K141625 | Polysyn Surgical SutureGAM · Special | Surgical Specialties Corp | 07/18/2014SE |
| K141558 | Quill Monoderm Knotless Tissue-Closure DeviceGAM · Special | Surgical Specialties Corp | 07/11/2014SE |
| K123940 | Demequicktm (Rapid Absorbable) Synthetic Surgical SutureGAM · Traditional | Demetech Corp. | 05/30/2014SE |
| K140227 | Monoderm Surgical SutureGAM · Special | Surgical Specialties Corp | 02/28/2014SE |
| K132580 | Coated Vicryl Plus Antimicrobial (Polyglactin 910) Synthetic Absorbable SutureGAM · Traditional | ETHICON, Inc. | 02/28/2014SE |
| K130737 | Synthetic Absorbable SutureGAM · Traditional | Foosin Medical Supplies Inc., Ltd. | 01/14/2014SE |
| K130735 | Synthetic Absorbable SutureGAM · Traditional | Foosin Medical Supplies Inc., Ltd. | 01/14/2014SE |
| K130083 | Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureGAM · Traditional | Demetech Corp. | 07/17/2013SE |
| K123836 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignGAM · Special | Surgical Specialties Corp. Dba Angiotech | 12/21/2012SE |
| K122734 | Aesculap Novosyn Absorbable SutureGAM · Traditional | Aesculap, Inc. | 12/18/2012SE |
| K123409 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignGAM · Traditional | Surgical Specialties Corp. Dba Angiotech | 11/20/2012SE |
| K122898 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignGAM · Traditional | Surgical Specialties Corp. Dba Angiotech | 10/22/2012SE |
| K120556 | Vilet Vilet QuickGAM · Abbreviated | Riverpoint Medical | 05/23/2012SE |
| K111442 | V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM)…GAM · Special | Covidien, Formerly US Surgical A Divison of Tyco H | 06/03/2011SE |
| K102592 | SutrazorbGAM · Abbreviated | Visionary Medical Supplies, Inc. | 02/03/2011SE |
| K100257 | VLOC9ABSORBABLE Wound Closure DeviceGAM · Traditional | Surgical Devices, A Division of Tyco Healthcare | 05/10/2010SE |
| K093408 | V-Loc 180 Absorbable Wound Closure DeviceGAM · Special | Surgical Devices, A Division of Tyco Healthcare | 11/12/2009SE |
| K091087 | Modification to V-Loc 180 Absorbable Wound Closure DeviceGAM · Special | Surgical Devices, Tyco Healthcare Group LP | 04/22/2009SE |
| K082662 | V-Loc 180 Absorbable Wound Closure DeviceGAM · Traditional | Surgical Devices, Tyco Healthcare Group LP | 03/26/2009SE |
| K080412 | Absorbable Synthetic Suture with Needle Attachment (Pga Braided)GAM · Traditional | Shanghai Pudong Jinhuan Medical Products Co., Ltd. | 09/04/2008SE |
| K081003 | Trusynth, Absorbable (Polyglactin 910) SutureGAM · Traditional | Sutures India Pvt., Ltd. | 06/09/2008SE |
| K081002 | Monoglyde, Absorbable (Poliglecaprone 25) SutureGAM · Traditional | Sutures India Pvt., Ltd. | 06/09/2008SE |
| K072863 | Atramat PGC25 Poly(Glycolide-Co-Epsilon-Caprolactone) Surgical SuturesGAM · Traditional | Internacional Farmaceutica, S.A. DE C.V. | 05/23/2008SE |
| K072859 | Atramat PGLA90 Poly(Glycolide-Co-L-Lactide) Surgical SuturesGAM · Traditional | Internacional Farmaceutica, S.A. DE C.V. | 05/23/2008SE |
| K073493 | Hepatostat SetGAM · Traditional | Vygon Corp. | 05/06/2008SE |
| K072646 | UnicaproneGAM · Traditional | United Medical Industries Co. , Ltd. | 11/07/2007SE |
| K072645 | UniglactinGAM · Traditional | United Medical Industries Co. , Ltd. | 11/07/2007SE |
| K072644 | Unicryl QuickGAM · Traditional | United Medical Industries Co. , Ltd. | 11/07/2007SE |
| K072229 | MonoswiftGAM · Abbreviated | Cp Medical | 10/05/2007SE |
| K072028 | Quill Self-Retaining System (SRS) Comprised of MonodermGAM · Traditional | Surgical Specialties Corp | 08/03/2007SE |
| K063536 | Polysorb* Synthetic Absorbable Suture with Modified PackagingGAM · Traditional | Tyco Healthcare Group | 01/29/2007SE |
| K063462 | Neatstitch Neatclose Suturing DeviceGAM · Traditional | Neat Stitch , Ltd. | 01/12/2007SE |
| K061796 | Hepatostat Set, Model 760XGAM · Traditional | Vygon Corp. | 11/02/2006SE |
| K062366 | Optime, Sinusorb PgaGAM · Traditional | Peters Surgical | 10/02/2006SE |
| K060801 | Dekna-Lok Model BP1000V2LGAM · Traditional | Teleflex Medical | 05/17/2006SE |
| K060828 | Modification to Endotine RibbonGAM · Special | Coapt Systems, Inc. | 04/19/2006SE |
| K053636 | Mani Needle & Suture Pack (Pga Absorbable)GAM · Traditional | Mani, Inc. | 03/14/2006SE |
| K052437 | Modified Monoderm Monofilament, Synthetic, Absorbable SutureGAM · Traditional | Surgical Specialties Corp | 11/07/2005SE |
| K051700 | Opticlean Lens Irrigator & Optidock Tissue LigatorGAM · Traditional | Medchannel, LLC | 08/15/2005SE |
| K050845 | Monocryl Plus Antibacterial SutureGAM · Traditional | ETHICON, Inc. | 06/29/2005SE |
| K051415 | Endotine RibbonGAM · Traditional | Coapt Systems, Inc. | 06/23/2005SE |
| K050771 | Lupine LoopGAM · Special | Depuy Mitek, A Johnson & Johnson Company | 04/08/2005SE |
| K041515 | Truglyde Absorbable Polyglycolic Acid Surgical SutureGAM · Traditional | Sutures India Private Limited | 04/08/2005SE |
| K050611 | Endotine RibbonGAM · Special | Coapt Systems, Inc. | 04/06/2005SE |
| K043539 | Demetech Sterile Synthetic Absorbable Sutures (Pga) and NeedlesGAM · Traditional | Demetech Corp. | 04/06/2005SE |
| K042288 | UnicrylGAM · Traditional | United Medical Industries Co. , Ltd. | 12/27/2004SE |
| K042233 | Passing Needle with Ethibond, Panacryl or Orthocord SutureGAM · Traditional | Depuy Mitek, A Johnson & Johnson Company | 09/28/2004SE |
| K042141 | Polyglytone 6211 Synthetic Absorbable SutureGAM · Traditional | Teleflex Medical | 09/28/2004SE |
| K041806 | Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle with…GAM · Traditional | Depuy Mitek, A Johnson & Johnson Company | 08/03/2004SE |
| K040477 | MonodermGAM · Traditional | Surgical Specialties Corp | 05/18/2004SE |
| K040282 | Atramat and Sorb-Fast Polyglycolic AcidGAM · Traditional | Internacional Farmaceutica, S.A. DE C.V. | 04/29/2004SE |
| K033762 | SerralapgGAM · Traditional | Serral, S.A. DE C.V. | 03/15/2004SE |
| K033746 | Modified Coated Vicryl* Rapide (Polyglactin 910) SutureGAM · Special | ETHICON, Inc. | 12/18/2003SE |
| K033115 | OrthodekGAM · Traditional | Teleflex Medical | 11/17/2003SE |
| K032586 | Caprosyn Absorbable SutureGAM · Abbreviated | United States Surgical, A Division of Tyco Healthc | 11/17/2003SE |
| K032698 | Coapt Endotine Midface-St 4.5 DeviceGAM · Traditional | Coapt Systems, Inc. | 10/23/2003SE |
| K032420 | Modified Coated Vicryl Plus Antibacterial (Polyglactin 910) Synthetic Absorbable SutureGAM · Traditional | ETHICON, Inc. | 10/22/2003SE |
| K031286 | Safil and Safil Quick Synthetic Absorbable Surgical SutureGAM · Special | Aesculap, Inc. | 05/29/2003SE |
| K023710 | Visorb SwiftGAM · Traditional | Cp Medical | 01/17/2003SE |
| K022715 | Coated Vicryl Plus Antimicrobial (Polyglactin 910) SutureGAM · Traditional | ETHICON, Inc. | 12/19/2002SE |
| K021767 | AssufilGAM · Traditional | Assut Europe S.P.A. | 11/19/2002SE |
| K022269 | Coated Vicryl* (Polyglactin 910) SutureGAM · Traditional | ETHICON, Inc. | 09/13/2002SE |
| K022664 | Pga (Polyglycolic) Synthetic Absorbable Suture U.S.P.GAM · Traditional | Arc Medical Supplies (Beijing) Co, Ltd. | 09/10/2002SE |
| K014021 | Sharpoint Coated, Fast Absorbing Polyglycolic Acid Synthetic Suture, UndyedGAM · Traditional | Surgical Specialties Corp | 01/28/2002SE |
| K013671 | L-25 Absorbable Surigcal SutureGAM · Abbreviated | United States Surgical, A Division of Tyco Healthc | 01/08/2002SE |
| K013177 | Multitak Suture Snap SystemGAM · Traditional | Bonutti Research, Inc. | 12/19/2001SE |
| K011372 | Aesculap, Inc. Safil Quick Synthetic Absorbable Surgical SutureGAM · Traditional | Aesculap, Inc. | 08/01/2001SE |
| K011375 | Aesculap, Inc., Monosyn Synthetic Absorbable Surgical SutureGAM · Traditional | Aesculap, Inc. | 06/29/2001SE |
| K010672 | Monograms Synthetic Monofilament Absorbable SutureGAM · Traditional | Gramsmed, LLC | 05/18/2001SE |
| K002639 | Bioknotless AnchorGAM · Traditional | Mitek Products | 05/11/2001SE |
| K003017 | Gramsorb Synthetic Absorbable SutureGAM · Traditional | Gramsmed, LLC | 03/13/2001SE |
| K002190 | Polyglycolic Acid (Pga), Absorbable Surgical Suture (Usp)GAM · Traditional | Cp Medical | 08/10/2000SN |
| K000037 | Monofilament Biosyn SutureGAM · Traditional | United States Surgical, A Division of Tyco Healthc | 03/30/2000SE |
| K994001 | Polyglycolic AcidGAM · Traditional | Trading Consultants and Distributors Intl., Inc. | 02/09/2000SE |
| K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGAM · Traditional | Genzyme Surgical Product (Genzyme Biosurgery) | 09/03/1999SE |
| K991191 | Bondek Polyglycolic Acid Synthetic Absorbable Surgical SutureGAM · Traditional | Genzyme Surgical Product (Genzyme Biosurgery) | 06/22/1999SE |
| K984374 | SurgisorbGAM · Traditional | Samyang Corp. | 06/04/1999SE |
| K990432 | SurgisorbGAM · Traditional | Sutures , Ltd. | 05/27/1999SN |
| K990951 | Maxon** Sterile, Synthetic, Absorbable SutureGAM · Traditional | United States Surgical, A Division of Tyco Healthc | 04/01/1999SE |
| K981935 | Polysorb SutureGAM · Traditional | United States Surgical, A Division of Tyco Healthc | 06/25/1998SE |
| K980610 | Dexon Rapid (Dexon R)GAM · Traditional | Davis & Geck, Inc. | 05/18/1998SE |
| K980704 | Safil Synthetic Absorbable Surgical SutureGAM · Traditional | Aesculap, Inc. | 05/11/1998SE |
| K974299 | PanacrylGAM · Traditional | ETHICON, Inc. | 02/13/1998SE |
| K972566 | Dexon VioletGAM · Traditional | Davis & Geck, Inc. | 08/14/1997SE |
| K971208 | Medline Industries, Inc. Orthopedic Trays/Kits/PacksGAM · Traditional | Medline Industries, Inc. | 05/13/1997SE |
| K970863 | Modified Ussc* Polysorb SutureGAM · Traditional | United States Surgical, A Division of Tyco Healthc | 05/05/1997SN |
| K970317 | Modified E-Pack Procedure KitGAM · Traditional | ETHICON, Inc. | 04/25/1997SE |
| K965162 | Lukens Pga, (Polyglycolic Acid) Synthetic Absorbable Surgical Suture,Coated…GAM · Traditional | Lukens Medical Corp. | 02/12/1997SE |
| K964345 | Ethicon Absorbable Poly (L-Lactide/Glycolide) Surgical Suture, UndyedGAM · Traditional | ETHICON, Inc. | 12/16/1996SE |
| K963253 | Synthetic Absorbable Surgical SutureGAM · Traditional | United States Surgical, A Division of Tyco Healthc | 10/08/1996SE |
| K962480 | Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable Suture, UndyedGAM · Traditional | ETHICON, Inc. | 08/02/1996SE |
| K961997 | Ussc Braided Synthetic Absorbable SutureGAM · Traditional | United States Surgical, A Division of Tyco Healthc | 07/16/1996SN |
| K953869 | Polysorb II Coated Synthetic Absorbable SutureGAM · Traditional | United States Surgical, A Division of Tyco Healthc | 10/18/1995SE |
| K951520 | Ussc Polysorb SutureGAM · Traditional | United States Surgical, A Division of Tyco Healthc | 08/21/1995SN |
| K945285 | Ussc Monofilament Polysorb SutureGAM · Traditional | United States Surgical, A Division of Tyco Healthc | 08/21/1995SN |
| K946271 | Vicryo* (Polyglactin 910) Braided Coated and Uncoated Synthetic Absorbable Suture, Dyed…GAM · Traditional | ETHICON, Inc. | 06/15/1995SE |
| K951352 | Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid SutureGAM · Traditional | Davis & Geck, Inc. | 06/05/1995SE |
| K944937 | Synthetic Absorbable SutureGAM · Traditional | Johnson & Johnson International | 05/19/1995SE |
| K944110 | Vicryl Rapide SutureGAM · Traditional | ETHICON, Inc. | 01/18/1995SN |
| K930772 | Ethicon* Monocryl (Poliglecaprone 25) SutureGAM · Traditional | ETHICON, Inc. | 01/07/1994SE |
| K930588 | Dexon S, Dexon Plus, and Dexon II Polycolic AcidGAM · Traditional | Davis & Geck, Inc. | 01/07/1994SE |
| K930360 | SuturesGAM · Traditional | ETHICON, Inc. | 12/17/1993SE |
| K930746 | Synthetic Absorbable Surgical SutureGAM · Traditional | United States Surgical, A Division of Tyco Healthc | 11/17/1993SE |
| K915835 | Coated Vicryl* IIGAM · Traditional | ETHICON, Inc. | 03/23/1992SE |
| K905482 | Bondek Polyglycolic Acid Synthetic Absorb. SutureGAM · Traditional | Pfizer Hospital Products Group, Inc. | 03/14/1991SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2919-2026 Class II | V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY…Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | Covidien, LP | 06/24/2026Open, Classified |
| Z-2918-2026 Class II | V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22…Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | Covidien, LP | 06/24/2026Open, Classified |
| Z-0319-2025 Class II | Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number…Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from… | Ethicon, Inc. | 09/25/2024Open, Classified |
| Z-2149-2024 Class II | MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general…Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility… | Ethicon, Inc. | 05/10/2024Open, Classified |
| Z-2146-2024 Class II | PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation…Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility… | Ethicon, Inc. | 05/10/2024Open, Classified |
| Z-2145-2024 Class II | VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft…Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility… | Ethicon, Inc. | 05/10/2024Open, Classified |
| Z-2144-2024 Class II | VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation…Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility… | Ethicon, Inc. | 05/10/2024Open, Classified |
| Z-1534-2024 Class II | POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503NComplaints have been received with allegations of Incorrect Needle Curvature. | Surgical Specialties | 03/26/2024Open, Classified |
| Z-1533-2024 Class II | STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX…Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during… | Ethicon, Inc. | 03/08/2024Open, Classified |
| Z-0201-2023 Class II | Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L…Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s)… | Covidien, LP | 09/28/2022Open, Classified |
| Z-0200-2023 Class II | Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L…Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s)… | Covidien, LP | 09/28/2022Open, Classified |
| Z-0150-2023 Class II | STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue…Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in… | Ethicon, Inc. | 09/20/2022Open, Classified |
| Z-1053-2022 Class II | STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code:…Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up. | Ethicon, Inc. | 03/24/2022Open, Classified |
| Z-0949-2021 Class II | Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24…Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength.… | Riverpoint Medical, LLC | 12/09/2020Terminated |
| Z-0398-2021 Class II | TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and…Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device). | Gordian Surgical | 09/22/2020Terminated |
| Z-0116-2021 Class II | VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product…Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct… | Ethicon, Inc. | 09/09/2020Terminated |
| Z-0049-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-13 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0048-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0047-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0046-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0045-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0044-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0043-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0042-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25 CV605…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0041-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0040-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0039-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0038-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0037-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0036-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0035-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-12 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0034-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0033-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" KV-34…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0032-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0031-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0030-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-14, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0029-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cut…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0028-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" CV-23 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0027-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0026-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" V-20 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0025-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0024-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" CV-25 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0023-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" P-10 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0022-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 VL 18" P-10, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0021-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" SC-1, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0020-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-12, Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0019-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0018-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0017-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-24, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |
| Z-0016-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | Riverpoint Medical, LLC | 08/03/2020Terminated |