Device Recall Ascension PyroHemiSphere (aka NuGrip)

Model / Serial
Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution: USA including states of: IL, IN, MD, OH, and TN; and countries of : Puerto Rico and Netherlands.
Product Description
The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469, is a single-use uncemented, one-component prosthesis for the basal thumb joint. || The NuGrip is intended to replace the proximal end of the first metacarpal.
Manufacturer
Ascension Orthopedics, Inc
1 Event
- Recall of Device Recall Ascension PyroHemiSphere (aka NuGrip)

Manufacturer

Ascension Orthopedics, Inc

Manufacturer Address
Ascension Orthopedics, Inc, 8700 Cameron Rd Ste 100, Austin TX 78754
Manufacturer Parent Company (2017)
Integra LifeSciences Holdings Corporation
Source
USFDA

One device with a similar name

Learn more about the data here

Device Recall Ascension PyroHemiSphere (aka NuGrip),

Model / Serial
Model #30-L NUG-443-30L, Catalog #NUG-443-30L, Lot #10-0731
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution: USA including states of: IL, IN, MD, OH, and TN; and countries of : Puerto Rico and Netherlands.
Product Description
The Ascension PyroHemiSphere (aka NuGrip), Model #30-L NUG-443-30L, Catalog #NUG-443-30L, Lot #10-0731, is a single-use uncemented, one-component prosthesis for the basal thumb joint. || The NuGrip is intended to replace the proximal end of the first metacarpal.
Manufacturer
Ascension Orthopedics, Inc

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