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Integra LifeSciences Corp. recalls CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cas
Recalled July 3, 2013 · FDA recall Z-1568-2013 · Integra LifeSciences
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. · FDA Class III
Units
467 devices
Sold at
USA Nationwide Distribution
Description
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.
Product
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.
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →