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Terminated

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 Recall Z-0813-2015 · Posted 2014-12-16

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeKWD
Date Initiated2014-11-06
Date Terminated2015-08-21
Product Quantity19 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

WA, Australia, and France

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060560ASCENSION PYROSPHERE CMC/TMTAscension Orthopedics, Inc. · 2006-05-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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