Z-1025-04

Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas

Name: Z-1025-04 Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas
Creator: Ascension Orthopedics, Inc
Published: 2003-10-02
License: https://open.fda.gov/license/

Ascension Orthopedics, Inc. / initiated 2003-10-02 / Terminated / root cause: packaging

FDA source

Ascension Orthopedics, Inc began a recall of Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas on 2003-10-02. The reason FDA records is "Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1025-04
Status: Terminated
Initiated: 2003-10-02
Posted: 2004-07-20
Terminated: 2004-06-17
Recalling firm: Ascension Orthopedics, Inc.
Product: Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas
Product code: NEG Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
Reason for recall: Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility.
Root cause tag: packaging
FDA root cause: Other
Action: Recall was initiated via letter included with replacement trays begining in October 2003.
Quantity in commerce: 107 trays
Distribution: Nationwide distrbution to IA, TX, OH, FL, IN, MN, CO, WA, CA, MO, and to a consignee in Ontario, Canada
Product codes and lots: All trays remaining in the marketplace are subject to the recall.

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)