Retractor
FDA product code GAD · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
100510(k) clearances
0PMA approvals
36recalls
Manufacturers
- T. Korossurgical Instruments Corp. 8
- Edward Weck, Inc. 4
- Karlin Technology, Inc. 3
- Minnesota Scientific, Inc. 3
- Kinetic Medical Products 3
- Medin Corp. 3
- The Huxley Instrument Corp. 3
- Imm Enterprises , Ltd. 2
- Adept-Med Intl., Inc. 2
- Zinnanti Surgical Instruments, Inc. 2
- The Anspach Effort, Inc. 2
- Ipax, Inc. 2
- American V. Mueller 2
- Automated Medical Products Corp. 2
- 3M Company 2
- Andronic Devices, Ltd. 2
- Cedar Surgical, Inc. 2
- Acme United Corp. 2
- J.R. Parker, LLC 1
- Boehringer Mannheim Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152538 | JRP Wound SpreaderGAD · Traditional | J.R. Parker, LLC | 04/13/2016SE |
| K151104 | Otelo LLGAD · Traditional | Spineart | 01/06/2016SE |
| K132645 | Thoratrak Mics Retractor System, Rack, BladesGAD · Traditional | Medtronic, Inc. | 10/04/2013SE |
| K071775 | DashGAD · Traditional | Ezsurgical | 08/07/2007SE |
| K050256 | Apple Medical/Ob Mobius Elastic RetractorGAD · Traditional | Apple Medical Corp. | 04/26/2005SE |
| K043602 | Quadrant Retractor SystemGAD · Traditional | Medtronic Sofamor Danek | 02/23/2005SE |
| K001339 | MRI Fastsystem Retractor SystemGAD · Special | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 05/17/2000SE |
| K980588 | Clarus Endoscopic Discectomy System Sitetrac Model 6000GAD · Traditional | Clarus Medical Systems, Inc. | 08/18/1998SE |
| K963006 | Scion Saphenous Vein Harvesting SystemGAD · Traditional | Scion International, Inc. | 09/20/1996SE |
| K943875 | Villalta RetractorGAD · Traditional | Hct, Inc. | 11/09/1994SE |
| K942002 | RetractorGAD · Traditional | Automated Medical Products Corp. | 05/17/1994SE |
| K941448 | RetractorGAD · Traditional | Technovations | 04/15/1994SE |
| K930316 | Lung Retractors: Davidson, SembGAD · Traditional | Thomasville Medical Assoc. | 02/10/1994SE |
| K926585 | Thorocoscopy Self-Retaining RetractorGAD · Traditional | T. Korossurgical Instruments Corp. | 08/06/1993SE |
| K921020 | Hargis Self Retraction SystemGAD · Traditional | Medin Corp. | 07/02/1993SE |
| K921019 | Hargis Rectal Self Retration SystemGAD · Traditional | Medin Corp. | 07/02/1993SE |
| K921017 | Hargis SR2 Self-Retraction SystemGAD · Traditional | Medin Corp. | 07/02/1993SE |
| K922626 | Adept Instrument Positioning AccessoryGAD · Traditional | Andronic Devices, Ltd. | 10/19/1992SE |
| K922625 | Adept Endoscopic PositionerGAD · Traditional | Andronic Devices, Ltd. | 10/19/1992SE |
| K920471 | Levy Articulating RetractorGAD · Traditional | Lifeguard Medical Products, Inc. | 06/23/1992SE |
| K914190 | Auto Suture(R) Endoscopic Fan RetractorGAD · Traditional | United States Surgical, A Division of Tyco Healthc | 05/06/1992SE |
| K915175 | Reddick RetractorGAD · Traditional | Ideal Medical, Inc. | 04/29/1992SE |
| K915158 | Surebreath Dome, E-Z BreatherGAD · Traditional | Ipax, Inc. | 02/12/1992SE |
| K910975 | Tekdyne Micro RetractorGAD · Traditional | Tekdyne | 04/01/1991SE |
| K903969 | Suction Retractor(Tower Attach.)For Crank Fram RetGAD · Traditional | Karlin Technology, Inc. | 09/05/1990SE |
| K893871 | Goott Balfour BladeGAD · Traditional | Adept-Med Intl., Inc. | 08/03/1989SE |
| K893869 | Goott Multipurpose Flexible Retractor (Sterile)GAD · Traditional | Adept-Med Intl., Inc. | 08/03/1989SE |
| K893121 | Robotrac (TM) Retractor ArmGAD · Traditional | Aesculap Instruments Corp. | 06/01/1989SE |
| K891892 | Rollet RetractorGAD · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K891031 | Kirschner RetractorGAD · Traditional | Zinnanti Surgical Instruments, Inc. | 04/06/1989SE |
| K890820 | Locking Wire Guide StyletGAD · Traditional | Medical Engineering and Development Institute | 03/22/1989SE |
| K890250 | Surgical Wire CuttersGAD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890248 | Surgical RetractorsGAD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890247 | Surgical RetractorsGAD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K884076 | Surebreath DomeGAD · Traditional | Ipax, Inc. | 10/07/1988SE |
| K882075 | Self-Retaining Soft Tissue RetractorGAD · Traditional | Karlin Technology, Inc. | 06/16/1988SE |
| K882074 | Suction RetractorsGAD · Traditional | Karlin Technology, Inc. | 06/16/1988SE |
| K882112 | Murse RetractorGAD · Traditional | Euro-American Marketing Group, Inc. | 06/15/1988SE |
| K881157 | Sternum Spreader and Mitral Valve RetractorGAD · Traditional | T. Korossurgical Instruments Corp. | 04/06/1988SE |
| K881159 | I.M.A. RetractorGAD · Traditional | T. Korossurgical Instruments Corp. | 04/05/1988SE |
| K881156 | Universal Sternum Spreader and I.M.A. RetractorGAD · Traditional | T. Korossurgical Instruments Corp. | 04/05/1988SE |
| K880998 | Sternum Spreader, PediatricGAD · Traditional | T. Korossurgical Instruments Corp. | 03/21/1988SE |
| K880997 | Spring RetractorGAD · Traditional | T. Korossurgical Instruments Corp. | 03/21/1988SE |
| K880813 | Self-Retaining Soft Tissue RetractorGAD · Traditional | T. Korossurgical Instruments Corp. | 03/11/1988SE |
| K880151 | Hip, Femur and Humerus RetractorGAD · Traditional | Twenty-First Century Orthopedics, Inc. | 02/18/1988SE |
| K875289 | Suction RetractorGAD · Traditional | T. Korossurgical Instruments Corp. | 01/22/1988SE |
| K874243 | Abdominal/Vascular Retractor-Split Wishbone 163000GAD · Traditional | Pilling Co. | 11/13/1987SE |
| K872919 | Omni-Tract Corral RetractorGAD · Traditional | Minnesota Scientific, Inc. | 08/11/1987SE |
| K870543 | Steri-Tractor Wound RetractorGAD · Traditional | 3M Company | 02/24/1987SE |
| K864424 | Raylor(Tm) Protective RetractorGAD · Traditional | Cedar Surgical, Inc. | 11/26/1986SE |
| K864384 | Luxtec Retractors, Luxtec Specialty RetractorsGAD · Traditional | Luxtec Corp. | 11/19/1986SE |
| K862597 | Various Surgical InstrumentsGAD · Traditional | Konig W.G., Ltd. | 07/23/1986SE |
| K853947 | Omni-Tract Chest Wall & Luna RetractorGAD · Traditional | Minnesota Scientific, Inc. | 10/16/1985SE |
| K853796 | Raylor RetractorsGAD · Traditional | Cedar Surgical, Inc. | 10/07/1985SE |
| K853114 | Rotalok Wrist Strap, Rotalok Skin RetractorGAD · Traditional | Australian Biomedical Corporation , Ltd. | 08/06/1985SE |
| K852415 | Titanium ProbesGAD · Traditional | L.A.S.E.R., Inc. | 08/02/1985SE |
| K852567 | 3M Fukuda Type Ring RetractorGAD · Traditional | 3M Company | 07/09/1985SE |
| K852530 | Weitianer Mastoid 3 VS 4 Blunt & Sharp ProngsGAD · Traditional | The Huxley Instrument Corp. | 06/28/1985SE |
| K852330 | Retractor, SurgicalGAD · Traditional | Scholten Surgical Instruments, Inc. | 06/27/1985SE |
| K851776 | 21-450 Gelpi RetractorGAD · Traditional | Artiberia | 06/20/1985SE |
| K851115 | Finocchieto Rib Retractor 1711-72 Pcs. SS 303, 420GAD · Traditional | The Huxley Instrument Corp. | 04/25/1985SE |
| K851108 | Volkman Retractor 699-576 Pcs. SHARP-4 Prongs SS42GAD · Traditional | The Huxley Instrument Corp. | 04/25/1985SE |
| K844177 | Cosgrove Mitral Valve RetractorGAD · Traditional | Kapp Surgical Instrument, Inc. | 11/08/1984SE |
| K843100 | Instruments for Micro AnastomosisGAD · Traditional | Downs Surgical , Ltd. | 09/27/1984SE |
| K843216 | Eclipse Heart Support for Coronary ArterGAD · Traditional | Biotrac Laboratories | 09/20/1984SE |
| K841625 | HookGAD · Traditional | Plastafil, Inc. | 08/27/1984SE |
| K842992 | Grasshopper - RetractorGAD · Traditional | Norton Texas Medical Products | 08/17/1984SE |
| K842762 | Omni-Tract Surgical Retractor SysGAD · Traditional | Minnesota Scientific, Inc. | 08/17/1984SE |
| K841009 | Surgical Retractors-VariousGAD · Traditional | Premier Dental Products Co. | 05/01/1984SE |
| K834142 | Adhesive Traction TapeGAD · Traditional | Devon Industries, Inc. | 04/23/1984SE |
| K834196 | Jakobi Surg. Instruments #11 20/25/27/37GAD · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
| K834181 | H.R. Jakobi Surg. Instruments #11 16/46GAD · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
| K832765 | Flexi-TyGAD · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/27/1984SE |
| K833541 | Surgical InstrumentGAD · Traditional | Hirata Sangyo Co. USA, Inc. | 11/28/1983SE |
| K830585 | Anvil RetractorGAD · Traditional | Twin City Surgical, Inc. | 05/27/1983SE |
| K830287 | Zimmer Skin ProtectorGAD · Traditional | Zimmer, Inc. | 03/09/1983SE |
| K820377 | Pilling Identi-LoopsGAD · Traditional | Narco Scientific | 03/10/1982SE |
| K820290 | Self Retaining Retractor for Hand SurgGAD · Traditional | The Anspach Effort, Inc. | 03/05/1982SE |
| K812875 | Surgical LoopsGAD · Traditional | M-W Laboratories, Inc. | 11/20/1981SE |
| K812389 | Surgical LoopsGAD · Traditional | Berkeley Medevices | 11/16/1981SE |
| K811759 | Retracting ProbesGAD · Traditional | American V. Mueller | 07/20/1981SE |
| K802599 | Arthroscopic Fat Pad RetractorGAD · Traditional | The Anspach Effort, Inc. | 10/31/1980SE |
| K801699 | Ethicon Retraction TapeGAD · Traditional | ETHICON, Inc. | 09/26/1980SE |
| K801759 | Effron Parotid RetractorGAD · Traditional | American V. Mueller | 08/20/1980SE |
| K801611 | Deep Balfour Blade for Wilkinson RetractGAD · Traditional | Edward Weck, Inc. | 08/04/1980SE |
| K792145 | Automatic Retractor HoldersGAD · Traditional | Automated Medical Products, Inc. | 12/05/1979SE |
| K781445 | SpreaderGAD · Traditional | Orthopedic Equipment Co., Inc. | 09/27/1979SE |
| K791665 | Scotts Surgical Retractor and ElasticGAD · Traditional | Lone Star Medical Products, Inc. | 09/19/1979SE |
| K791122 | Tissure RetractorsGAD · Traditional | Xomed, Inc. | 07/10/1979SE |
| K790952 | Clamp CoversGAD · Traditional | Medi-Spec | 06/05/1979SE |
| K780720 | Identi-LoopsGAD · Traditional | Berkeley Bio-Medical, Inc. | 10/17/1978SE |
| K780993 | Ultrasound Imaging SystemGAD · Traditional | Boehringer Mannheim Corp. | 08/10/1978SE |
| K780708 | Automatic Retractor HolderGAD · Traditional | Great Eastern Lumber Co., Inc. | 07/17/1978SE |
| K772378 | Neivs Tracheotomy RetractorGAD · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K771191 | Heiss RetractorGAD · Traditional | Edward Weck, Inc. | 07/11/1977SE |
| K770414 | Probe Retractor, Part #S-2L8-6GAD · Traditional | Acme United Corp. | 04/15/1977SE |
| K770651 | Retractors & Hooks, AbramsonGAD · Traditional | Edward Weck, Inc. | 04/14/1977SE |
| K770418 | Retractor, Skin HookGAD · Traditional | Acme United Corp. | 03/23/1977SE |
| K761096 | Vanderbilt Pituitary RetractorGAD · Traditional | Codman & Shurtleff, Inc. | 11/30/1976SE |
| K760422 | Surgical RetractorGAD · Traditional | Cutter Laboratories, Inc. | 08/23/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2714-2026 Class II | OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences… | Integra LifeSciences Corp. (NeuroSciences) | 06/05/2026Open, Classified |
| Z-1765-2025 Class II | Centurion Sterile Weitlaner Retractor, Reorder: 67315Three is the potential for the retractors to puncture through the sterile packaging. | MEDLINE INDUSTRIES, LP - Northfield | 04/09/2025Open, Classified |
| Z-0933-2025 Class II | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2)…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |
| Z-2235-2024 Class II | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm…Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure | Seaspine Orthopedics Corporation | 05/17/2024Open, Classified |
| Z-2234-2024 Class II | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm…Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure | Seaspine Orthopedics Corporation | 05/17/2024Open, Classified |
| Z-1434-2024 Class II | Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | MEDLINE INDUSTRIES, LP - Northfield | 02/23/2024Open, Classified |
| Z-1184-2024 Class II | Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and…Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration… | Medagent Inc | 12/21/2023Open, Classified |
| Z-2097-2023 Class II | Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractorThere are incomplete pre-cleaning instructions within the Instructions for Use (IFU). | Teleflex LLC | 05/25/2023Open, Classified |
| Z-2096-2023 Class II | Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractorThere are incomplete pre-cleaning instructions within the Instructions for Use (IFU). | Teleflex LLC | 05/25/2023Open, Classified |
| Z-0953-2023 Class II | RadiaLux Lighted Retractor (Pink), REF: 50-101-1Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination… | Medtronic Navigation, Inc. | 12/08/2022Open, Classified |
| Z-2818-2020 Class II | Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to…The products were improperly heat treated. | Smith & Nephew, Inc. | 08/03/2020Open, Classified |
| Z-1675-2020 Class II | aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00The company has become aware that the soft tissue retractor is not always removed during the sawing process.… | AAP Implantate Ag | 11/28/2019Terminated |
| Z-3278-2018 Class II | Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The…There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of… | CooperSurgical, Inc. | 09/04/2018Terminated |
| Z-1759-2018 Class II | Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores… | Synthes (USA) Products LLC | 04/02/2018Terminated |
| Z-1758-2018 Class II | Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores… | Synthes (USA) Products LLC | 04/02/2018Terminated |
| Z-1611-2016 Class II | Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a…The firm received a complaint of an open pouch which breaches the sterilization validation. | Applied Medical Technology Inc | 02/17/2016Terminated |
| Z-1610-2016 Class II | Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation…The firm received a complaint of an open pouch which breaches the sterilization validation. | Applied Medical Technology Inc | 02/17/2016Terminated |
| Z-1609-2016 Class II | TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not…The firm received a complaint of an open pouch which breaches the sterilization validation. | Applied Medical Technology Inc | 02/17/2016Terminated |
| Z-1608-2016 Class II | TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE…The firm received a complaint of an open pouch which breaches the sterilization validation. | Applied Medical Technology Inc | 02/17/2016Terminated |
| Z-1093-2016 Class II | Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet…Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor)… | Biomet, Inc. | 02/16/2016Terminated |
| Z-0566-2016 Class II | Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in…AAG received a customer complaint that corrosion had been found by a hospitals central sterile service… | Aesculap, Inc. | 11/17/2015Terminated |
| Z-2418-2015 Class II | Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve…Potential for micropores to form, allowing fluid to enter the hollow handle. | Synthes (USA) Products LLC | 07/29/2015Terminated |
| Z-0973-2015 Class II | Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft…Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured… | Synthes, Inc. | 12/15/2014Terminated |
| Z-0092-2015 Class II | DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715Particle residue on the instrument from adhesive tape which was used to bind the device during transport.… | Synthes, Inc. | 10/02/2014Terminated |
| Z-1457-2014 Class II | The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to…The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of… | Synthes, Inc. | 02/11/2014Terminated |
| Z-0341-2014 Class II | Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation…The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened. | Synthes USA HQ, Inc. | 09/24/2013Terminated |
| Z-0429-2014 Class II | Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy…The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction. | Synthes USA HQ, Inc. | 08/01/2013Terminated |
| Z-0031-2014 Class II | UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during…Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the… | Aesculap, Inc. | 07/16/2013Terminated |
| Z-1783-2013 Class II | Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131…The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed… | Pemco Inc | 07/10/2013Terminated |
| Z-2155-2012 Class II | LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I…Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base… | Stryker Spine | 04/23/2012Terminated |
| Z-0498-2010 | ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520 The ILLICO Posterior…The recall was initiated after Alphatec Spine received a complaint on the ILLICO Posterior Thoracolumbar… | Alphatec Spine, Inc. | 01/28/2009Terminated |
| Z-0567-2009 | Retractors Model #'s: ADE3204 BOS820-175 LON3304 and LON3334-4G A manual surgical…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | Sterilmed Inc | 08/08/2008Terminated |
| Z-0316-2007 | Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and…The soft tissue pin in the retractor can break off and become embedded in the tissue. | Whiteside Biomechanics | 09/15/2006Terminated |
| Z-0214-2007 | Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, model #1110…Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized… | Lone Star Medical Products, Inc | 10/06/2004Terminated |
| Z-0213-2007 | Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107…Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized… | Lone Star Medical Products, Inc | 10/06/2004Terminated |
| Z-0212-2007 | Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1104…Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized… | Lone Star Medical Products, Inc | 10/06/2004Terminated |