Recall Z-2709-2011 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Medacta Usa Inc
Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versafitcup Double Mobility Liner Inserter Model Number: 01.26.10.0018 The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patients condition should be due to one or more of: " Severely painful and/or disabled j
| Date | Jun 30, 2011 (initiated May 23, 2011) |
| Status | Terminated |
| Reason | Medacta International has recently realized that the base of the Liner Inserter Ref 01.26.10.0018 Lot 105549 of the Versafitcup Double Mobility system could become rusty after the washing procedures. This is due to an incorrect raw material used by one of our suppliers during the production phase of this lot. For this reason, Medacta International has made the decision to remove all the pieces |
| Root cause | Labeling False and Misleading |
| Action | Medacta USA sent an "URGENT SAFETY NOTIFICATION-VERSAFITCUP DM LINER INSERTER" letter dated May 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected device, immediately sequester it and not use the device in surgery. The letter instructs customers to pack the affected device for shipment to Medacta USA under Return Material Authorization 1590. Customer will receive a replacement within a few days. Questions regarding this recall are directed to t |
| Quantity | Worldwide: 18 pieces. In the USA: 9 pieces |
| Distribution | Worldwide Distribution--USA (nationwide) including the states of CA, ID, IL, and OH, and 9 products to foreign countries. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083116 | VERSAFIT CUP DOUBLE MOBILITY SYSTEM Medacta International S.A., Apr 7, 2009 |