Alerta De Seguridad para PFC KNEE SYSTEM - ANVISA Registration No. 10132590647 - Lots: 77217A, 81343A and 79709A

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

After gamma radiation, this vacuum sealing provides an oxygen-free environment for polyethylene, reducing its oxidation potential. Research indicates that prolonged natural aging of gamma-sterilized polyethylene in the presence of air can reduce long-term performance. It was determined that the loss of vacuum encountered only in a small percentage of the products occurred due to incomplete sealing resulting from the use of an unapproved sealing technique. The sealing of the outer carton is intact and therefore the sterility of the product has not been compromised. In addition to the corrective actions implemented, DePuy also began a comprehensive sampling of existing inventories to see if any other employee could have used unapproved techniques producing similar results. The final analysis of this sampling identified that another employee might be using a similar technique. Therefore, DePuy is expanding the scope of the initial recall to include other product and lot codes. These products are no longer being distributed and we believe most, if not all, of them have been deployed. In most cases, the natural aging time prior to the implant was relatively short and therefore the long-term performance impairment is minimal. No adverse events were found in products already implanted abroad.