Class 2 Device Recall Synthes Guide Blocks for the Volar Distal Radius Plate System

• Date Initiated by Firm: May 29, 2014
• Date Posted: July 21, 2014
• Recall Status: Terminated on August 18, 2016
• Recall Number: Z-2087-2014
• Recall Event ID: 68442
• Product Classification: orthopedic manual surgical instrument - Product Code LXH
• Product: Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
• Code Information: part no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147
• Recalling Firm/ Manufacturer: Synthes, Inc.; 1302 Wrights Ln E; West Chester PA 19380-3417
• For Additional Information Contact: Customer Support; 610-719-5000
• Manufacturer Reason for Recall: The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct.
• FDA Determined Cause: Process control
• Action: An urgent field correction notification, dated May 29, 2014, was sent to end users and sales consultants which described the product, problem, and actions to be taken.
• Quantity in Commerce: 180
• Distribution: Distribution US Nationwide and Bermuda.
• 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.