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U.S. Department of Health and Human Services

Class 2 Device Recall Cobalt HV Bone Cement

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  Class 2 Device Recall Cobalt HV Bone Cement see related information
Date Initiated by Firm June 26, 2017
Date Posted November 06, 2017
Recall Status1 Open3, Classified
Recall Number Z-0065-2018
Recall Event ID 77801
510(K)Number K091608  
Product Classification Bone cement - Product Code LOD
Product Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS
Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures
Code Information Lot Numbers: 507830, 871270, 959670
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Neeta Sharma
512-832-9500
Manufacturer Reason
for Recall		 Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
FDA Determined
Cause 2		 Vendor change control
Action Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 2017 to all affected customers. The firm initiated their recall to their distributors on 06/26/2017 requesting that they destroy any product on hand. The firm then expanded their recall on 09/14/2017, beginning their notification by email and following with letters to hospitals delivered on 09/21 and 09/22/2017. The firm requested the following actions: "1. Complete the Acknowledgement/Questionnaire provided with this lot specific field safety notice and return to Stericycle by email to DJO5504@stericycle.com or by fax to 866-608-3939. If you have any questions or issues related to sending this information, please call 877-551-7153. 2. Quarantine this affected product. Arrangements will be made to finalize the handling of the product as well as coordinate the replacement product where applicable. 3. If packaging issues are found, please contact DJO Surgical Customer Service to initiate a product complaint." Customers with questions were instructed to call 512-834-6255.
Quantity in Commerce 840 units
Distribution 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LOD and Original Applicant = BIOMET MANUFACTURING CORP.
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