Class 2 Device Recall Trinica

• Date Initiated by Firm: August 24, 2004
• Date Posted: October 23, 2004
• Recall Status: Terminated on November 03, 2005
• Recall Number: Z-0040-05
• Recall Event ID: 29908
• Product Classification: Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
• Product: ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
• Code Information: Serial Numbers: ATO-001 through ATO-0082
• 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: To date, there has been one complaint reported. During a Trinica surgical case, the surgeon was provided a standard disposable, Trinica Drill Bit (part number 07.00166.001) for use with the Trinica All Through One Drill Guide Instrumentation, instead of the ALL Through One Drill Bit. This enabled the physician to drill a few millimeters further than expected.
• FDA Determined Cause: Other
• Action: The product distributed to accounts will be returned to Zimmer Spine. Product will be quarantined pending investigation and determination of appropriate corrective action.
• Quantity in Commerce: 82 sets
• Distribution: Product was distributed nationwide throughout the United States. Product was not distributed outside of 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.