Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension Orthopedics, 8700 Cameron Road, Suite 100, Austin, Texas 78754; TEL: 512 836-5001. Intended as an accessory to the Ascension PyroCarbon PIP Total Joint used in finger joint implant procedures where the joint has become painful, stiff or cannot move because of arthritis.
FDA Recall Z-1524-2010 · Posted 2010-05-04
Recalling FirmAscension Orthopedics, Inc
Recall StatusTerminated
Product CodeNEG
Date Initiated2009-06-17
Date Terminated2010-09-27
Product Quantity129 units (64 US, 65 OUS)
Reason for Recall
Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant.
Firm Action
Ascension Orthopedics, Inc. issued e-mail notification to distributors and sales representatives beginning June 2009. Consignees were instructed return affected product to the firm for replacement.
For further information, contact Ascension Orthopedics, Inc. at 1-512-836-5001 extension 1549.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - Worldwide Distribution - United States, United Kingdom, France, Australia, Belgium, Czech Republic, Canada, Germany, The Netherlands and South Africa.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.