Devices

Device Recall Endotec TMJ Components

Model / Serial
Lot No: 09110215NN373 09110216NN373 09110217NN379 09420216NN373 09520217NN379
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution -- US in OH, TX, CA, FL, NJ, TN; and International Distribution: Korea, Australia, Switzerland, The Netherlands, Spain. Domestic: OH, TX, CA, FL, NJ, TN.
Product Description
TMJ Components: || Right Ramus Component - DelCristo Catalog: 09-11-0215, || TMJ - Shah Catalog: 09-42-0217, 09-11-0217. || Left Fossa Component - DelCristo Catalog 09-42-0216, || Left Ramus Component - DelCristo Catalog: 09-11-0216.
Manufacturer
Endotec, Inc.
1 Event
- Recall of Device Recall Endotec TMJ Components

Manufacturer

Endotec, Inc.

Manufacturer Address
Endotec, Inc., 2546 Hansrob Rd, Orlando FL 32804-3318
Manufacturer Parent Company (2017)
Cellumed Co., Ltd.
Source
USFDA

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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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