Recall Z-1246-2015 ยท MBB Bone Cement, Antibiotic
DePuy Orthopaedics, Inc.
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.
| Date | Mar 5, 2015 (initiated Feb 11, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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- |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033563 | SMARTSET GHV GENTAMICIN BONE CEMENT DePuy Orthopaedics, Inc., Feb 5, 2004 |