Ascension® NuGrip®
Ascension Orthopedics, Inc. · Model NUG44330M · UDI-DI 10381780120100
Description
The Ascension® NuGrip® is an uncemented, one-component prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® NuGrip® is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-08 | Wright Medical Technology, Inc. | The firm discovered a lack of adequate documentation confirming sterility on certain products. |
| 2013-06-03 | Integra LifeSciences Corp. | As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content |
| 2010-07-12 | Ascension Orthopedics, Inc | Two different product lots were found to be incorrectly labeled and placed into the incorrect box. |
| 2010-07-12 | Ascension Orthopedics, Inc | Two different product lots were found to be incorrectly labeled and placed into the incorrect box. |
| 2003-01-24 | Avanta Orthopaedics, Inc. | Wrong silicone elastomer used in construction. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs