FDA Device recall Z-0813-2015
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th…
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th… by Integra Lifesciences, citing integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0813-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-06 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | WA |
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
Reason
Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.
Identifiers
| code_info | Lot numbers: 140098T and 140929T |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0813-2015%22
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