Class 3 Device Recall Holding Forceps for Trident Acetabular System

• Date Initiated by Firm: January 24, 2007
• Date Posted: December 16, 2009
• Recall Status: Terminated on December 21, 2009
• Recall Number: Z-0539-2010
• Recall Event ID: 52384
• Product Classification: Forceps - Product Code HTD
• Product: Holding Forceps for Trident Acetabular System; non Sterile;; Catalog number 2105-0000;; Howmedica Osteonics Corp, 325 Corporate Drive,; Mahwah, NJ 07430;; Authorized representative in Europe:; Stryker France, Cedex. France; ; The Holding Forceps for Acetabular trial cups help facilitate the insertion / correction of the Acetabular trial inserts.
• Code Information: All lots beginning with V1 (XXX).
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430
• For Additional Information Contact: Rita Intorella; 201-831-5825
• Manufacturer Reason for Recall: The tips of the forceps were larger than the positioning holes located on the trials and the implant liners.
• FDA Determined Cause: Pending
• Action: Important Product Correction letters, dated January 24, 2007, were sent to all consignees on via Federal Express. The letter stated the problem and asked customers to examine their inventory and hospital locations to identify the affected product. All affected forceps product should be retrieved from hospitals and returned to their branch or agency warehouse for reconciliation. Customers are also to reconcile all affected product on the attached Product Accountability Form and fax a copy of that form to 201-831-6069 within 5 days of receipt of the letter. All affected forceps product is to be destroyed and discarded at their branch location. Questions should be directed to their Stryker Orthopaedics Customer Service rep at 1-866-OR-ASSIST.
• Quantity in Commerce: 351 units
• Distribution: Worldwide Distribution -- Including countries of Hong Kong, Australia, Japan, New Zealand, Hong Kong, Singapore, Germany, Sweden, The Netherlands, France, Spain, Portugal, and the United Kingdom.
• 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.