Recall Z-0770-2013 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Zimmer, Inc.
Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
| Date | Feb 4, 2013 (initiated Sep 14, 2012) |
| Status | Terminated |
| Reason | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. |
| Root cause | Process control |
| Action | Zimmer sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated September 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.The firm expanded the scope of the recall in January 2013 to include devices that use a secondary mean of fixation. New recall letters will be submitted to distributors and surgeons. |
| Quantity | 275,952 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980711 | HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING Zimmer, Inc., Nov 12, 1998 |