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U.S. Department of Health and Human Services

Class 2 Device Recall Bone Dowell Harvest Tubes

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  Class 2 Device Recall Bone Dowell Harvest Tubes see related information
Date Initiated by Firm April 12, 2017
Date Posted April 25, 2017
Recall Status1 Terminated 3 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 2		 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.
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