Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitari
FDA device recall Z-0549-03 · posted 2003-02-08 · Terminated
Recall details
- Recalling firm
- Ascension Orthopedics, Inc
- Reason for recall
- Brochures approved for international distribution only were distributed domestically.
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 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
- Date initiated
- 2002-10-31
- Date posted
- 2003-02-08
- Date terminated
- 2003-12-03
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.