Aesculap Implant Systems LLC AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

Recommended Action

Per FDA guidance

On January 21, 2020, the firm distributed Urgent Medical Device Recall Notification letters to affected customers. Customers were informed that LDPE particles may be present on the surface of implants upon the opening of the inner packaging. The firm has developed a new packaging configuration to mitigate the issue. Until the product in the field is removed and replaced with product in the new packaging configuration, the firm has taken immediate action to limit the transportation cycles of the product to six months. Customers were asked to immediately examine their inventory and identify product subject to recall. In addition, if customers have further distributed the product, please identify customers and notify them at once of the recall. Customers should NOT destroy affected product. Customers were asked to complete the customer response form and indicate the total number of units in their possession. A representative of Aesculap will reach out to customer facilities to schedule site visits for removal of affected product and replacement of inventory.