Device product
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
Z-0813-2015
Product summary
- Event
- Event 69719
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 units
- Official record key
device-enforcement:Z-0813-2015
Official wording
Reason: Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.
Code information: Lot numbers: 140098T and 140929T
Distribution pattern: WA, Australia, and France
Derived failure modes
-
Unknown
Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.