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
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-0549-03
- Quantity
- Unknown at this time
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Brochures approved for international distribution only were 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, SC, VA, MD, PA, MA, CT, VT, ME, ID, LA, WI, NE
Lot / Code Info
Removal domestically of literature Document: LC-04-207-001
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 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.