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U.S. Department of Health and Human Services

Class 2 Device Recall SMARTSET GHV Gentamicin Bone Cement

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  Class 2 Device Recall SMARTSET GHV Gentamicin Bone Cement see related information
Date Initiated by Firm February 11, 2015
Date Posted March 05, 2015
Recall Status1 Terminated 3 on May 19, 2015
Recall Number Z-1246-2015
Recall Event ID 70507
510(K)Number K033563  
Product Classification Bone cement, antibiotic - Product Code MBB
Product SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis.
Code Information Cat. No. 545035500, Lot No. 7915797
Recalling Firm/
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Tia L. Holmes-Johnson
Manufacturer Reason
for Recall
One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.
FDA Determined
Cause 2
Under Investigation by firm
Action DePuy Orthopaedics, Inc. sent an Urgent Information - Recall Notice dated February 6, 2015, to all affected consignees for a voluntary recall of one lot of SMARTSET¿ GHV Gentamicin Bone Cement because the affected cement is partially agglomerated (clumped together). Consignees were instructed to discontinue use of the affected lot of bone cement immediately and destroy according to the consignees hazardous materials protocol or return if Certified Dangerous Goods Shipper, holding an International Air Transport Association (IATA) certification. Customers were instructed to call 574-371-4917 (M-F; 8 am  5 pm EST). For questions regarding this recall call 574-371-4577.
Quantity in Commerce 1267
Distribution Nationwide Distribution including CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MS, MT, NC, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WV.
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 = MBB and Original Applicant = DEPUY ORTHOPAEDICS, INC.