Class 3 Device Recall Ascension PIP

• Date Initiated by Firm: October 31, 2002
• Date Posted: February 08, 2003
• Recall Status: Terminated on December 03, 2003
• Recall Number: Z-0549-03
• Recall Event ID: 25056
• HDE Number: H010005
• Product Classification: unknown device name - Product Code ---
• Product: 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
• Code Information: Removal domestically of literature Document: LC-04-207-001
• Recalling Firm/ Manufacturer: Ascension Orthopedics, Inc; 8200 Cameron Road, Ste C-140; Austin TX 78754-3832
• Manufacturer Reason for Recall: Brochures approved for international distribution only were distributed domestically.
• FDA Determined 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 in Commerce: 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

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.