FDA-Device2013-07-03Class III
CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.
Integra LifeSciences Corp.
Hazard
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 that is cleared by FDA.
Sold states
USA Nationwide Distribution
Affected count
467 devices
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1568-2013Don't want to check this manually?
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