Class 2 Device Recall Bone Dowell Harvest Tubes

• Date Initiated by Firm: April 12, 2017
• Date Posted: April 25, 2017
• Recall Status: Terminated on November 03, 2017
• Recall Number: Z-2059-2017
• Recall Event ID: 77113
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: Bone Dowell Harvest Tubes
• Code Information: Part Number: 900738 Lot Number (LN): 889990
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: Customer Service; 800-348-2759
• Manufacturer Reason for Recall: mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 4/12/2017 URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
• Quantity in Commerce: 49
• Distribution: No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND
• 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.