FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0813-2015
- Recalling firm
- Integra LifeSciences Corp.
- 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
- Status
- Terminated
- Initiated
- 2014-11-06
- Posted
- 2014-12-16
- Terminated
- 2015-08-21
- 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
- Lot, serial or model codes
- Lot numbers: 140098T and 140929T
- 510(k) numbers
- ["K060560"]
- PMA numbers
- not on file
- Product code
- KWD
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28