Z-1524-2010

Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension...

Name: Z-1524-2010 Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension...
Creator: Ascension Orthopedics, Inc
Published: 2009-06-17
License: https://open.fda.gov/license/

Ascension Orthopedics, Inc. / initiated 2009-06-17 / Terminated / root cause: design

FDA source

Ascension Orthopedics, Inc began a recall of Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension Orthopedics, 8700 Cameron Road, Suite 100, Austin, Texas... on 2009-06-17. The reason FDA records is "Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1524-2010
Status: Terminated
Initiated: 2009-06-17
Posted: 2010-05-04
Terminated: 2010-09-27
Recalling firm: Ascension Orthopedics, Inc.
Product: 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.
Product code: NEG Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
Reason for recall: Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 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.
Product codes and lots: All lot codes.

Product code NEG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)