Class 2 Device Recall Zimmer Spine formerly Centerpulse SpineTech

• Date Initiated by Firm: May 21, 2004
• Date Posted: February 24, 2005
• Recall Status: Terminated on November 03, 2005
• Recall Number: Z-1014-04
• Recall Event ID: 29200
• 510(K)Number: K022344
• Product Classification: Tap, Bone - Product Code HWX
• Product: Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.
• Code Information: Lot P020077.
• Recalling Firm/ Manufacturer: Zimmer Spine, Inc.; 7375 Bush Lake Rd; Minneapolis MN 55439-2027
• For Additional Information Contact: Kimberly Tokach; 952-830-6205
• Manufacturer Reason for Recall: The recalled bone taps could break inside the vertebral body during the tapping process.
• FDA Determined Cause: Other
• Action: Recall letters, dated May 25, 2004, request that the consignees locate and return the recalled devices.
• Quantity in Commerce: 55 units
• Distribution: The product was shipped to Hawaii, New York, South Carolina, and South Dakota in the United States.
• 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.

• 510(K) Database: 510(K)s with Product Code = HWX