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U.S. Department of Health and Human Services

Class 2 Device Recall COLUMBUS CRA/PSA TIB.PLAT.CEMENTED

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  Class 2 Device Recall COLUMBUS CRA/PSA TIB.PLAT.CEMENTED see related information
Date Initiated by Firm January 21, 2020
Create Date March 13, 2020
Recall Status1 Open3, Classified
Recall Number Z-1480-2020
Recall Event ID 84865
510(K)Number K053390  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product 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.
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 2
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = AESCULAP, INC.
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