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U.S. Department of Health and Human Services

Class 2 Device Recall Cobalt Bone Cement

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  Class 2 Device Recall Cobalt Bone Cement see related information
Date Initiated by Firm April 13, 2017
Date Posted April 25, 2017
Recall Status1 Terminated 3 on March 26, 2019
Recall Number Z-2056-2017
Recall Event ID 77116
510(K)Number K051496  K091908  
Product Classification Bone cement - Product Code LOD
Product Cobalt HV Bone Cement
Cobalt MV Bone Cement
Cobalt HV Bone Cement With Gentamicin
Code Information Model numbers: 402282 and 402282J - Cobalt HV Bone Cement 402438 - Cobalt MV Bone Cement 402283J - Cobalt HV Bone Cement With Gentamicin  402438 Lot: 507830  402282J Lot: 668140  402282 Lot: 508220  402283J Lot: 189780 
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 4/13/2017 URGENT MEDICAL DEVICE RECALL  LOT SPECIFIC 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 4238
Distribution TX. Japan Mexico
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 = LOD and Original Applicant = BIOMET, INC.
510(K)s with Product Code = LOD and Original Applicant = SPECTRUM MEDICAL LTD
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