Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and th
FDA device recall Z-0813-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KWD
- Quantity affected
- 19 units
- Distribution
- WA, Australia, and France
- Date initiated
- 2014-11-06
- Date posted
- 2014-12-16
- Date terminated
- 2015-08-21
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASCENSION PYROSPHERE CMC/TMT (K060560) | Ascension Orthopedics, Inc. | 2006-05-05 |