Ascension Orthopedics PyroSphere CMC & PyroSphere TMT recall
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th…
Why was Ascension Orthopedics PyroSphere CMC & PyroSphere TMT recalled?
Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: 140098T and 140929T
- Product
- Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 19 units
- Distribution
- WA, Australia, and France
- Recall date
- December 24, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)