Conmed
Conmed Electrosurgical Handpiece, Hand Controlled With Blade Electrode, TIP Cleaner, Rocker Switch, Safety Holster AND 10FT (3M) Cable
65manufacturers in China registered for this device type
186catalogue numbers in this listing
25510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K854864 |
| Record published | 2016-09-24 |
| Record revised | 2026-04-17 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 95 % RH; Storage environment temperature -29 to 149 °F; Storage environment temperature -34 to 65 °C |
| Packaging | Box of 40, carton, carton of 10, box of 10, carton of 40, box of 25 |
| Sizes | Length 0.375 to 8.25 in; angle 30 to 90 °; length 4.5 to 33 cm; outer diameter 0.5 to 12.7 mm; length 3 to 4.5 m; length 10 to 15 ft; outer diameter 0.09375 to 0.75 in; length 110 to 200 mm |
| Distribution end date | 2026-03-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 7-809-8 | Length 7 in | In distribution | |
| 60-8005-DOD | In distribution | ||
| 714 | Length 0.375 in | In distribution | |
| 60-7403-001 | Outer Diameter 0.5 mm | In distribution | |
| 60-1767-001 | Jewlers Micro-Tip | In distribution | |
| 60-1771-001 | Semkin with Stops | In distribution | |
| B210 | In distribution | ||
| 60-5626-001 | In distribution | ||
| 138110 | Length 6 in | 40 | In distribution |
| T205 | In distribution | ||
| 60-6700-001 | In distribution | ||
| 138104NSB | 200 | In distribution | |
| 60-1774-001 | Curved Iris | In distribution | |
| 130188 | 25 | In distribution | |
| 130316-15NS | 10 | In distribution | |
| 60-5480-001 | In distribution | ||
| 130320 | 250 | In distribution | |
| 60-0824-001 | In distribution | ||
| 137668 | In distribution | ||
| 60-8040-002 | In distribution | ||
| 138004 | 5 | In distribution | |
| 60-0930-002 | In distribution | ||
| 133002 | In distribution | ||
| AES-FC | In distribution | ||
| T229 | In distribution | ||
| 60-1768-001 | 5 Inches | In distribution | |
| 130146 | In distribution | ||
| 138026 | 5 | In distribution | |
| 138104 | 40 | In distribution | |
| 135166 | Length 3.66 m | 40 | In distribution |
| 60-8040-001 | In distribution | ||
| 60-5122-001 | Jewlers Straight | In distribution | |
| B204 | In distribution | ||
| T228 | In distribution | ||
| 138112 | Length 10 cm | 40 | In distribution |
| 138008 | In distribution | ||
| 60-1770-001 | Hardy Bayonet | In distribution | |
| 700 | In distribution | ||
| 60-5103-002 | In distribution | ||
| 60-5104-003 | In distribution | ||
| 714-S | Outer Diameter 0.375 in | In distribution | |
| AES-50S | Length 13 cm | In distribution | |
| 60-0930-001 | In distribution | ||
| AES-90SN | Angle 90 ° | In distribution | |
| 138103 | 3/16 Inch Ball Electrode | 40 | In distribution |
| 7-900-7 | In distribution | ||
| 60-5132-001 | In distribution | ||
| 133001 | In distribution | ||
| 60-5104-001 | In distribution | ||
| AES-HK20 | In distribution | ||
| 60-5103-001 | In distribution | ||
| B230 | In distribution | ||
| 138010 | 5 | In distribution | |
| 60-5123-001 | 5.5 Inch | In distribution | |
| 7-809-12 | 12 FT | In distribution | |
| 60-7404-001 | Outer Diameter 1 mm | In distribution | |
| 7-796-18CS | 1,200 | In distribution | |
| 138012 | 3/4 Inch Loop Electrode Diameter | 5 | In distribution |
| 60-5130-001 | In distribution | ||
| T257 | In distribution | ||
| 7-222-L | Outer Diameter 0.21875 in | In distribution | |
| 138107 | Length 6 in | 40 | In distribution |
| 138107NSB | 100 | In distribution | |
| 60-5121-001 | Bayonet | In distribution | |
| 60-8034-001 | In distribution | ||
| AES-HK00 | In distribution | ||
| 60-1772-001 | Semkin Straight | In distribution | |
| 705A | Angle 75 ° | In distribution | |
| AES-90SL | 18 CM | In distribution | |
| 130317-10NS | 10 | In distribution | |
| 7-809-6 | Length 7.5 in | In distribution | |
| 2-1008 | Outer Diameter 5 mm | In distribution | |
| 130304A | Length 3 m | In distribution | |
| 7-809-4 | Length 5 in | In distribution | |
| 60-5773-001 | In distribution | ||
| 138110NSB | 100 | In distribution | |
| AES-30 | Angle 30 ° | In distribution | |
| 130317-15 | Length 4.5 m | 10 | In distribution |
| T229-5M | In distribution | ||
| 60-0823-001 | In distribution | ||
| 135166NSB | Length 12 ft | 250 | In distribution |
| 7-796-19CS | 100 | In distribution | |
| AES-1 | In distribution | ||
| 138102 | 40 | In distribution | |
| 138105 | 40 | In distribution | |
| 7-221-S | Length 2 in | In distribution | |
| 60-0812-001 | Hand-Switching | In distribution | |
| SN-UAC | In distribution | ||
| 138108 | Length 6 in | 40 | In distribution |
| 60-7152-001 | In distribution | ||
| 7-809-5 | Length 7 in | In distribution | |
| B205 | In distribution | ||
| T238 | In distribution | ||
| AES-FCE | 10 | In distribution | |
| AES-WFC | In distribution | ||
| B227 | In distribution | ||
| 7-809-7 | In distribution | ||
| 138101 | 40 | In distribution | |
| 60-0869-001 | 6 | In distribution | |
| 60-7401-001 | Length 200 mm | In distribution | |
| 7-809-9 | Length 7.5 in | In distribution | |
| 138105NSB | 200 | In distribution | |
| 7-809-1 | Length 4 in | In distribution | |
| 6050P | 50 | In distribution | |
| AES-50SL | 18 CM | In distribution | |
| 130317 | 10 | In distribution | |
| 60-1765-001 | In distribution | ||
| 60-1769-001 | 7.5 Inches | In distribution | |
| T235 | In distribution | ||
| 60-2121-001 | Length 10 ft | 50 | In distribution |
| B210R | In distribution | ||
| 138102NSB | 200 | In distribution | |
| 136051 | In distribution | ||
| 138113 | Length 3.5 in | 40 | In distribution |
| 711B | Angle 45 ° | In distribution | |
| 7-221-A | Outer Diameter 0.75 in | In distribution | |
| 60-6102-002 | 12 FT | 10 | In distribution |
| 138011 | 1/4 Inch Loop Electrode Diameter | 5 | In distribution |
| 7-796-18BX | 100 | In distribution | |
| 138018 | 10 | In distribution | |
| 60-8041-001 | In distribution | ||
| 7-222-A | Angle 30 ° | In distribution | |
| 7-796-19BX | In distribution | ||
| 138019 | 5 | In distribution | |
| 7-809-2 | Length 7 in | In distribution | |
| T210 | In distribution | ||
| 7-809-3 | Length 8.25 in | In distribution | |
| B260 | In distribution | ||
| 60-7400-001 | Length 200 mm | In distribution | |
| 60-1773-001 | Straight Iris | In distribution | |
| 60-8046-001 | 12 FT | In distribution | |
| 60-6790-001 | In distribution | ||
| 7-221-L | Outer Diameter 0.625 in | In distribution | |
| 7-796-20 | In distribution | ||
| 138100 | 40 | In distribution | |
| A238 | In distribution | ||
| 60-1766-001 | Jewlers Micro-Tip | In distribution | |
| 60-0860-001 | 6 | In distribution | |
| 138652A | Length 3 m | 40 | Withdrawn |
| 138008 | 1/4 Inch Conization | Withdrawn | |
| 60-0137-001 | Withdrawn | ||
| AES-50S | Angle 50 ° | Withdrawn | |
| 138107NSB | Length 6 in | 100 | Withdrawn |
| 138019 | Length 1.75 in | 5 | Withdrawn |
| 705A | Angle 75 ° | Withdrawn | |
| 138018 | Ball Electrode Diameter | 10 | Withdrawn |
| 130316-10NS | 10 | Withdrawn | |
| 60-0860-001 | 6 | Withdrawn | |
| T229-5M | Withdrawn | ||
| 60-5102-002 | Length 3.05 m | 10 | Withdrawn |
| 138110NSB | Length 15 cm | 100 | Withdrawn |
| 7-900-7 | Withdrawn | ||
| 135166NSB | Length 3.66 m | 250 | Withdrawn |
| 130320 | 250 | Withdrawn | |
| 60-6700-001 | Withdrawn | ||
| 130316-15 | Length 15 ft | 10 | Withdrawn |
| T205 | Withdrawn | ||
| 138004 | Needle Electrode | 5 | Withdrawn |
| 130316 | 10 | Withdrawn | |
| 60-5103-001 | Withdrawn | ||
| SN-UAC | Withdrawn | ||
| 130317-15NS | 10 | Withdrawn | |
| 714 | Length 0.375 in | 6 | Withdrawn |
| 138104NSB | 200 | Withdrawn | |
| 138010 | 3/8 Inch Loop Electrode Diameter | 5 | Withdrawn |
| T229 | Withdrawn | ||
| T210 | Withdrawn | ||
| 60-5104-001 | Withdrawn | ||
| 60-8031-001 | Withdrawn | ||
| T257 | Withdrawn | ||
| AES-WFC | Withdrawn | ||
| 60-0930-001 | Withdrawn | ||
| 138102NSB | 200 | Withdrawn | |
| T228 | Withdrawn | ||
| 7-796-18CS | 1,200 | Withdrawn | |
| 138101NSB | 200 | Withdrawn | |
| AES-30 | Length 8.5 cm | Withdrawn | |
| 60-0869-001 | 6 | Withdrawn | |
| AES-FC | Withdrawn | ||
| 714-S | Angle 30 ° | 6 | Withdrawn |
| 138105NSB | 200 | Withdrawn | |
| 60-0930-002 | Withdrawn | ||
| 700 | 5 | Withdrawn | |
| 138026 | 5 | Withdrawn | |
| 60-5806-001 | Withdrawn | ||
| 7-796-18BX | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 5,729 |
| Speedlock | National Advanced Endoscopy Devices, Inc. | 5,212 |
| Stingray Surgical Products | Stingray Surgical Products L.L.C. | 4,647 |
| Kirwan | Kirwan Surgical Products, LLC. | 1,901 |
| Millennium | Avalign Technologies, Inc. | 1,779 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 1,590 |
| Elmed | Elmed, Inc. | 1,519 |
| Symmetry Olsen | Aspen Surgical Products, Inc. | 1,219 |
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 1,117 |
| Ambler Surgical | Ambler Surgical, LLC | 756 |
| V. Mueller | Steris Corporation | 661 |
| Aesculap | Aesculap AG | 544 |
Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231732 | 2023-10-23 |
| K230547 | 2023-04-27 |
| K214058 | 2022-08-26 |
| K221945 | 2022-07-28 |
| K213354 | 2022-03-11 |
| K172671 | 2017-10-04 |
| K151229 | 2016-06-02 |
| K152860 | 2015-12-29 |
| K153499 | 2015-12-18 |
| K140578 | 2014-07-23 |
| K140459 | 2014-07-11 |
| K140658 | 2014-07-10 |
| K123260 | 2012-12-21 |
| K120476 | 2012-06-12 |
| K120322 | 2012-06-12 |
| K103665 | 2011-02-16 |
| K100686 | 2010-05-21 |
| K100047 | 2010-05-14 |
| K081644 | 2008-09-10 |
| K081634 | 2008-06-25 |
| K081580 | 2008-06-19 |
| K062082 | 2007-01-25 |
| K052104 | 2005-10-21 |
| K052009 | 2005-09-28 |
| K041868 | 2004-09-28 |
Recalls Naming This Product
15 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ConMed Corporation | 510(k) number | 2022-11-18 | Class II | Process control | Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to | 23,700 US; 5,225 OUS | 2026-04-13 |
| Olsen Medical | 510(k) number | 2018-05-11 | Class II | Package design/selection | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. | 323,886 devices | 2019-04-15 |
| Olsen Medical | 510(k) number | 2018-05-11 | Class II | Package design/selection | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. | 71,890 devices | 2019-04-15 |
| ConMed Corporation | 510(k) number | 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 955 units | 2012-08-30 |
| ConMed Corporation | 510(k) number | 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 45 units | 2012-08-30 |
| ConMed Corporation | 510(k) number | 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 530 units | 2012-08-30 |
| ConMed Corporation | 510(k) number | 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 60 units | 2012-08-30 |
| ConMed Corporation | 510(k) number | 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 3176 units | 2012-08-30 |
| ConMed Corporation | 510(k) number | 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 165 units | 2012-08-30 |
| ConMed Corporation | 510(k) number | 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 106 units | 2012-08-30 |
| ConMed Corporation | 510(k) number | 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 508 units | 2012-08-30 |
| ConMed Corporation | 510(k) number | 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 409 units | 2012-08-30 |
| ConMed Corporation | 510(k) number | 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 67 units | 2012-08-30 |
| ConMed Corporation | 510(k) number | 2006-03-27 | Not classified | Other | Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures. | 5205 units | 2012-04-27 |
| ConMed Corporation | 510(k) number | 2006-03-27 | Not classified | Other | Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures. | 3496 units | 2012-04-27 |
Recalls
37 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-02-28 | Class II | Mixed-up of materials/components | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to | ||
| 2017-02-28 | Class II | Mixed-up of materials/components | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to | ||
| 2017-02-28 | Class II | Mixed-up of materials/components | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to | ||
| 2017-02-28 | Class II | Mixed-up of materials/components | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to | ||
| 2017-02-28 | Class II | Mixed-up of materials/components | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to | ||
| 2016-05-18 | Class II | Device Design | A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. | 6,640 units | 2018-05-24 |
| 2016-05-18 | Class II | Device Design | A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. | 4,480 units | 2018-05-24 |
| 2016-05-18 | Class II | Device Design | A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. | 124,333 units | 2018-05-24 |
| 2016-05-18 | Class II | Device Design | A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. | 307,684 units | 2018-05-24 |
| 2016-05-18 | Class II | Device Design | A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. | 4,560 units | 2018-05-24 |
| 2015-11-05 | Class II | Process control | Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece’s temperature. This causes some devices to generate a “Check Seal” message with an audible a | 9 devices | 2018-05-24 |
| 2015-06-17 | Class II | Software design (manufacturing process) | Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage. | 276 devices | 2017-04-11 |
| 2014-05-08 | Class II | Nonconforming Material/Component | ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed. | Domestic – 12,600 units, Foreign – 44,280 units | 2017-04-11 |
| 2014-02-20 | Class II | Device Design | ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns. | 12,653 units (10,769 domestically & 1,884 internationally) | 2017-04-07 |
| 2013-10-23 | Class II | Material/Component Contamination | The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk | 147 handpieces (Domestic: 135 devices; Foreign: 12 devices) | 2017-03-08 |
| 2013-10-23 | Class II | Material/Component Contamination | The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk | 65 handpieces (Domestic: 41 devices; Foreign: 24 devices) | 2017-03-08 |
| 2013-01-28 | Class II | Equipment maintenance | Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. | Domestic Distribution: 97,450 units; Foreign Distribution: 6 | 2017-04-11 |
| 2013-01-28 | Class II | Equipment maintenance | Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. | Domestic Distribution: 97,450 units; Foreign Distribution: 6 | 2017-04-11 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
| 2012-05-07 | Not classified | Equipment maintenance | An investigation of the ConMed Electrosurgery Altrus Energy Source revealed that the device could have been calibrated incorrectly resulting in error messages or delays in surgery. | 122 units | 2012-06-19 |
| 2012-05-07 | Not classified | Process control | The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding. | 18 units | 2012-06-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.