Z-1482-2020Class II

COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K...

Name: Z-1482-2020 COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K...
Creator: Aesculap Implant Systems LLC
Published: 2020-01-21
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2020-01-21 / Terminated / root cause: manufacturing process

FDA source

Aesculap Implant Systems LLC began a recall of COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z... on 2020-01-21. FDA classified it as Class II and gives the reason as "Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1482-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-21
Posted: 2020-03-13
Terminated: 2021-09-22
Recalling firm: Aesculap Inc
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: All product with old packaging configuration. New packaging configuration begins with Lot 52533610.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1482-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1478-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1479-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1480-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1481-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1482-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13

Product code JWH

K083772Class IIColumbus Revision Knee SystemAesculap Implant System, Inc. / cleared 2009-06-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)