Recall Z-0549-03 ยท ---
Ascension Orthopedics, Inc
Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005
| Date | Feb 8, 2003 (initiated Oct 31, 2002) |
| Status | Terminated |
| Reason | Brochures approved for international distribution only were 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 inititate an examination of all pertinent professional labeling in their stock, and request return of incorrect labeling. The firm initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request. |
| Quantity | Unknown at this time |
| Distribution | AL, AZ, NM, TX, FL, NJ, CA, IL, TN, MS, OH, KY, IN, MN, NY, OR, WA, CO, PA, UT, MO, OK, NC, SC, VA, MD, PA, 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.