Recall Z-0550-03 ยท ---
Ascension Orthopedics, Inc
Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal
| Date | Feb 8, 2003 (initiated Oct 31, 2002) |
| Status | Terminated |
| Reason | Literature approved for international distribution only was distributed domestically. |
| Root cause | Other |
| 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.