Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT Recalled by Integra LifeSciences Corp. Due to Integra LifeSciences has determined that a portion of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.
Affected Products
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
Quantity: 19 units
Why Was This Recalled?
Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.
Where Was This Sold?
This product was distributed to 1 state: WA
About Integra LifeSciences Corp.
Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report