FDA-Device2014-12-24Class II
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW
Integra LifeSciences Corp.
Hazard
Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.
Sold states
WA, Australia, and France
Affected count
19 units
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0813-2015Don't want to check this manually?
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