Z-0550-03

Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal

Name: Z-0550-03 Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal
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 MCP, Prosthesis, Finger Joint, Metacarpophalangeal on 2002-10-31. The reason FDA records is "Literature approved for international distribution only was distributed domestically". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0550-03
Status: Terminated
Initiated: 2002-10-31
Posted: 2003-02-08
Terminated: 2003-12-03
Recalling firm: Ascension Orthopedics, Inc.
Product: Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal
Product code: ---
Reason for recall: Literature approved for international distribution only was 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 initiate an examination of all Ascension MCP professional labeling in their stock, and request return of incorrect labeling. The firm additionally, initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.
Quantity in commerce: Currently being determined
Distribution: AL, AZ, NM, TX, FL, NJ, CA, IL, TN, MS, OH, KY, IN, MN, NY, OR, WA, CO, PA, UT, MO, OK, NC, VA, SC, MD, MA, CT, VT, ME, ID, LA, WI, NE
Product codes and lots: Brochure intended for international distribution, Document: LC-04-107-011

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)