Class 2 Device Recall Ascension PIP

• Date Initiated by Firm: October 02, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on June 17, 2004
• Recall Number: Z-1025-04
• Recall Event ID: 29035
• HDE Number: H010005
• Product Classification: Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis - Product Code NEG
• Product: Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas
• Code Information: All trays remaining in the marketplace are subject to the recall.
• Recalling Firm/ Manufacturer: Ascension Orthopedics, Inc; 8200 Cameron Rd Ste C-140; Austin TX 78754-3832
• Manufacturer Reason for Recall: Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility.
• FDA Determined Cause: Other
• Action: Recall was initiated via letter included with replacement trays begining in October 2003.
• Quantity in Commerce: 107 trays
• Distribution: Nationwide distrbution to IA, TX, OH, FL, IN, MN, CO, WA, CA, MO, and to a consignee in Ontario, Canada
• Total Product Life Cycle: TPLC Device Report

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.

• HDE Database: HDEs with Product Code = NEG and Original Applicant = Smith & Nephew, Inc.