COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K 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.
- Company
- Aesculap Implant Systems Llc
- Recall Initiated
- January 21, 2020
- Terminated
- September 22, 2021
- Recall Number
- Z-1480-2020
- Firm Location
- Center Valley, PA
Reason for Recall
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, OH, OK, OR, PA, TN, TX, UT, WA and countries of Saudi Arabia, Utd. Arab Emir., Argentina, Austria, Australia, Bosnia-Herz., Bulgaria, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Germany, Algeria, Ecuador, Estonia, Spain, United Kingdom, Georgia, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Libya, Moldavia, Mexico, Malaysia, Nigeria, Netherlands, Poland, Portugal, Paraguay, Russian Fed., Singapore, El Salvador, Thailand, Turkey, Ukraine, South Africa.
Lot / Code Info
All product with old packaging configuration. New packaging configuration begins with Lot 52533610.
Root Cause
Material/Component Contamination
Action Taken
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.