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U.S. Department of Health and Human Services

Class 2 Device Recall Bone Cement

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  Class 2 Device Recall Bone Cement see related information
Date Initiated by Firm July 26, 2016
Date Posted August 19, 2016
Recall Status1 Terminated 3 on January 13, 2017
Recall Number Z-2606-2016
Recall Event ID 74800
510(K)Number K051496  
Product Classification Bone cement - Product Code LOD
Product Cobalt HV Bone Cement

Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
Code Information Lot 507970
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Desiree Wells
Manufacturer Reason
for Recall
The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.
FDA Determined
Cause 2
Labeling mix-ups
Action The recalling firm sent an Urgent Field Safety Notice letter dated July 26 2016 to Sales Agents. The letter identified the affected product, problem and actions to be taken. The sales agents were instructed to pass on the notice to any organization where the potential affected product has been transferred. Agents were instructed to identify hospitals in their territory, complete a visually inspection of the affected product in the hospital's inventory, complete an Acknowledgement and Receipt form. If affected products is found contact Customer Service at 1-800-456-8696 for replacement.
Quantity in Commerce 866 units
Distribution US Nationwide Distribution
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.