Devices

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
1 Event
- Recall of Device Recall Monodek

Manufacturer

Teleflex Medical

Manufacturer Address
Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA

One device with a similar name

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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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