Recalls / —
—#131421
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
- FDA product code
- KWD — Prosthesis, Toe, Hemi-, Phalangeal
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K060560
- Affected lot / code info
- Lot numbers: 140098T and 140929T
Why it was recalled
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 (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- WA, Australia, and France
Timeline
- Recall initiated
- 2014-11-06
- Posted by FDA
- 2014-12-16
- Terminated
- 2015-08-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #131421. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.