Recall Z-0813-2015— Integra LifeSciences Corp.

Name: FDA recall Z-0813-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-06

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2014-11-06, terminated 2015-08-21. It names one FDA 510(k) clearance: K060560. 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..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-11-06
Terminated: 2015-08-21
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K060560 — ASCENSION PYROSPHERE CMC/TMTAscension Orthopedics, Inc.·cleared 2006-05-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.