Z-0813-2015Class II

Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first...

Name: Z-0813-2015 Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first...
Creator: Integra LifeSciences Corp.
Published: 2014-11-06
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2014-11-06 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal... on 2014-11-06. FDA classified it as Class II and gives the reason as "Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0813-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-06
Posted: 2014-12-16
Terminated: 2015-08-21
Recalling firm: Integra LifeSciences Corporation
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
Product code: KWD Prosthesis, Toe, Hemi-, Phalangeal
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 19 units
Distribution: WA, Australia, and France
Product codes and lots: Lot numbers: 140098T and 140929T

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0813-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0813-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-16

Product code KWD

K060560Class IIAscension Pyrosphere Cmc/tmtAscension Orthopedics, Inc. / cleared 2006-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)