Devices

Device Recall Monode

Model / Serial
Model #: 02200002 All units received from the manufacture prior to the week of July 12, 2015
Product Classification
Physical Medicine Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide in the states of WY, OH, WA, NC, FL, NE, GA, KS CA, MO, IN, MA, IL, OK, AZ, TX, AR, UT, NJ, WI, PA, SC, WV, NY, MI, MN, VA, AK, TN, OR, NC, NH, KY, CO, NV, ID and the countries of El Salvador, China, Ecuador, South Korea, Chile, Israel, Peru, Nicaragua, Bolivia, Indonesia
Product Description
Monode, Shortwave Accessory || Model #: 02200002 || Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.
Manufacturer
DJO, LLC
1 Event
- Recall of Device Recall Monode

Manufacturer

DJO, LLC

Manufacturer Address
DJO, LLC, 1430 Decision St, Vista CA 92081-8553
Manufacturer Parent Company (2017)
The Blackstone Group LP
Source
USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Monodek

Model / Serial
Product Code: 833-137, Batch: 02H1103434, 02H1200349, and 02K1201354.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution -- USA, including the state of MA, and the country of Germany
Product Description
Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
Manufacturer
Teleflex Medical

Device Recall Monodek Sutures

Model / Serial
NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Lot #2503061, 2503063, 2761528, 2761529 2694983, 3152877, 3169994, 2395967, 3163970 & 3232258; Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V, Lot #2360982 & 2381287.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
Product Description
Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V
Manufacturer
Teleflex Creek Dr

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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