CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report

Ascension Orthopedics PyroSphere CMC & PyroSphere TMT recalled

Integra LifeSciences is recalling Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint, distributed in Washington. The recall was initiated on 6 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers: 140098T and 140929T

Quantity recalled19 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0813-2015
FDA event ID: 69719
Recalling firm: Integra LifeSciences, Plainsboro, NJ
Classification: Class II
Status: Terminated
Recall initiated: 6 Nov 2014
FDA classified: 16 Dec 2014
Reported: 24 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

6 Nov 2014	Recall initiated by company
16 Dec 2014	Classified by FDA	+40 days
24 Dec 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

WA, Australia, and France

Washington

Questions about this recall

Why was it recalled?

Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.

Which lots are affected?

Lot numbers: 140098T and 140929T

Where was it sold?

WA, Australia, and France

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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