Recall Z-0813-2015 ยท KWD Prosthesis, Toe, Hemi-, Phalangeal
Integra LifeSciences Corp.
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
| Date | Dec 16, 2014 (initiated Nov 6, 2014) |
| Status | Terminated |
| Reason | Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque. |
| Root cause | Nonconforming Material/Component |
| Action | The firm sent out written notification of the recall on 11/6/14. The letter instructed the consignees to quarantine and return any affected product. |
| Quantity | 19 units |
| Distribution | WA, Australia, and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060560 | ASCENSION PYROSPHERE CMC/TMT Ascension Orthopedics, Inc., May 5, 2006 |