Z-0549-03

Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received...

Name: Z-0549-03 Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received...
Creator: Ascension Orthopedics, Inc
Published: 2002-10-31
License: https://open.fda.gov/license/

Ascension Orthopedics, Inc. / initiated 2002-10-31 / Terminated

FDA source

Ascension Orthopedics, Inc began a recall of Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitarian Device Exemption approval on March... on 2002-10-31. The reason FDA records is "Brochures approved for international distribution only were distributed domestically". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0549-03
Status: Terminated
Initiated: 2002-10-31
Posted: 2003-02-08
Terminated: 2003-12-03
Recalling firm: Ascension Orthopedics, Inc.
Product: Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005
Product code: ---
Reason for recall: Brochures approved for international distribution only were distributed domestically.
FDA root cause: Other
Action: The firm began to contact all US distributors on October 31, 2002 and all US sales representatives on November 1, 2002, by e-mail to inititate an examination of all pertinent professional labeling in their stock, and request return of incorrect labeling. The firm initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.
Quantity in commerce: Unknown at this time
Distribution: AL, AZ, NM, TX, FL, NJ, CA, IL, TN, MS, OH, KY, IN, MN, NY, OR, WA, CO, PA, UT, MO, OK, NC, SC, VA, MD, PA, MA, CT, VT, ME, ID, LA, WI, NE
Product codes and lots: Removal domestically of literature Document: LC-04-207-001

Product code ---

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)