10 results
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57ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension Orthopedics, 8700 Cameron Road, Suite 100, Austin, Texas 78754; TEL: 512 836-5001. Intended as an accessory to the Ascension PyroCarbon PIP Total Joint used in finger joint implant procedures where the joint has become painful, stiff or cannot move because of arthritis.
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code NEG·June 17, 2009
Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754. Orthopedic manual surgical screwdriver.
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code HXX·April 14, 2009
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
FDA Enforcement
Class III
·Terminated·Ascension Orthopedics, Inc·February 13, 2019
Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code ---·October 31, 2002
Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm, 17.5 mm, and 19.0 mm each with stem sizes 4.5 mm, 5.5 mm, or 6.5 mm. The First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint. The Partial Head implant is indicated for replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code KXE·December 3, 2011
Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code NEG·October 2, 2003
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.
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code KYI·July 12, 2010
Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code ---·October 31, 2002
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.
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code KYI·July 12, 2010
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code HSD·November 16, 2018