Class 2 Device Recall COLUMBUS REV F TIBIA OFFSET CEMENTED

• Date Initiated by Firm: January 21, 2020
• Create Date: March 13, 2020
• Recall Status: Terminated on September 22, 2021
• Recall Number: Z-1482-2020
• Recall Event ID: 84865
• 510(K)Number: K083772
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z NR077K NR077Z NR078K NR078Z NR079K NR079Z 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.
• Code Information: All product with old packaging configuration. New packaging configuration begins with Lot 52533610.
• Recalling Firm/ Manufacturer: Aesculap Implant Systems LLC; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: Lindsay Chromiak; 610-984-9072 Ext. 5072
• Manufacturer Reason for Recall: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
• FDA Determined Cause: Material/Component Contamination
• Action: 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.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JWH