Z-2418-2010

NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size...

Name: Z-2418-2010 NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size...
Creator: Zimmer Inc.
Published: 2010-04-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-04-26 / Terminated

FDA source

Zimmer Inc. began a recall of NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 10, sterile, REF 00-5950-057-04, Zimmer Inc. Warsaw... on 2010-04-26. The reason FDA records is "The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2418-2010
Status: Terminated
Initiated: 2010-04-26
Posted: 2010-09-13
Terminated: 2011-03-28
Recalling firm: Zimmer GmbH
Product: NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 10, sterile, REF 00-5950-057-04, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device.
FDA root cause: Other
Action: The firm, Zimmer, Inc., sent an "URGENT DEVICE CORRECTION" letter dated April 26, 2010, to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to destroy or disregard all previous versions of the surgical technique, review the attached revised surgical technique to familiarize yourself with the modifications and warnings, and complete and return the Health Care Professional Dcoumentation Form via fax to Zimmer, Inc. at (574) 372-4265. (Note: Zimmer made a modification to the surgical technique and instructions for use. They added a warning to fully cement and pressurize the anterior and posterior surfaces of the tibial component, and to strongly recommend the use of a drop down stem extension. This change was completed and approved on April 23, 2010.) For questions please contact Zimmer at 1-877-946-2761.
Quantity in commerce: 68,384 all products
Distribution: Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.
Product codes and lots: 103105, 104265, 7881970, 60276810, 60292622, 60296127, 60296128, 60312270, 60505320, 60505321, 60505323 and 60892882.

Product code JWH

K043101Class IINexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem ExtensionsZimmer, Inc. / cleared 2005-03-07

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)