Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal

FDA Recall Z-0550-03 · Posted 2003-02-08

Recalling FirmAscension Orthopedics, Inc
Recall StatusTerminated
Date Initiated2002-10-31
Date Terminated2003-12-03
Product QuantityCurrently being determined

Reason for Recall

Literature approved for international distribution only was distributed domestically.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑