Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension Orthopedics, 8700 C
FDA device recall Z-1524-2010 · posted 2010-05-04 · Terminated
Recall details
- Recalling firm
- Ascension Orthopedics, Inc
- Reason for recall
- Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant.
- Action taken
- 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
- Status
- Terminated
- Product code
- NEG
- Quantity affected
- 129 units (64 US, 65 OUS)
- Distribution
- Worldwide Distribution - Worldwide Distribution - United States, United Kingdom, France, Australia, Belgium, Czech Republic, Canada, Germany, The Netherlands and South Africa.
- Date initiated
- 2009-06-17
- Date posted
- 2010-05-04
- Date terminated
- 2010-09-27
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.