FDA Device

Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal

Hazard

Literature approved for international distribution only was distributed domestically.

What You Should Do

Remedy

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.

Products

Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal
Brand
Ascension Orthopedics, Inc
UPC
Brochure intended for international distribution, Document: LC-04-107-011

Units Affected

Currently being determined