RecallDepth

Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal

Company
Ascension Orthopedics, Inc
Recall Initiated
October 31, 2002
Posted
February 8, 2003
Terminated
December 3, 2003
Recall Number
Z-0550-03
Quantity
Currently being determined
Firm Location
Austin, TX

Reason for Recall

Literature approved for international distribution only was distributed domestically.

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

Lot / Code Info

Brochure intended for international distribution, Document: LC-04-107-011

Root Cause

Other

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.

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