Integra LifeSciences Corp.: Medical Device Recall in 2014 - (Recall #: Z-0813-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: November 6, 2014

Date Posted: December 24, 2014

Recall Number: Z-0813-2015

Event ID: 69719

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.

Status: Terminated

Product Quantity: 19 units

Code Information:

Lot numbers: 140098T and 140929T

Distribution Pattern:

WA, Australia, and France

Voluntary or Mandated:

Voluntary: Firm initiated