Devices

Device Recall Ascension Orthopedics PyroSphere CMC & PyroSphere TMT

Model / Serial
Lot numbers: 140098T and 140929T
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
WA, Australia, and France
Product Description
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW
Manufacturer
Integra LifeSciences Corp.
1 Event
- Recall of Device Recall Ascension Orthopedics PyroSphere CMC & PyroSphere TMT

Manufacturer

Integra LifeSciences Corp.

Manufacturer Address
Integra LifeSciences Corp., 311 Enterprise Dr, Plainsboro NJ 08536-3344
Manufacturer Parent Company (2017)
Integra LifeSciences Holdings Corporation
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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