Recall Z-1066-2014 ยท MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Smith & Nephew Inc
Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral os
| Date | Feb 21, 2014 (initiated Jan 23, 2014) |
| Status | Terminated |
| Reason | Inner spherical radius of the shell is undersized. |
| Root cause | Under Investigation by firm |
| Action | Smith & Nephew Inc. sent an Urgent - Product Recall 1st Notification letter dated January 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Actions for Hospital Representatives: 1. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. 2. Complete the last two columns in the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned, and include your phone and fax number in |
| Quantity | 10 units |
| Distribution | Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960094 | REFLECTION DUAL DIMENSION SHELL Smith & Nephew Richards, Inc., Mar 27, 1996 |