Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal
This recall has been terminated (originally issued February 8, 2003).
- 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
- Official Source
- View on FDA website ↗
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.