Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal

FDA device recall Z-0550-03 · posted 2003-02-08 · Terminated

Recall details

Recalling firm

Ascension Orthopedics, Inc

Reason for recall

Literature approved for international distribution only was distributed domestically.

Action taken

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

Status

Terminated

Quantity affected

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

Date initiated

2002-10-31

Date posted

2003-02-08

Date terminated

2003-12-03

Location

Austin, TX