Skip to content

NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial… recallZ-0437-2013 · Zimmer, Inc. · initiated Sep 21, 2012

Class II Terminated All recalls posted in November 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Zimmer is initiating a lot specific recall of the NexGen Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters. As a result, the devices may contain residual particulate from the manufacturing process. Risks include: Allergic reaction due to the foreign material or late onset

FDA root cause category: Process change control

What the company is doing

Zimmer sent an Urgent Medical Device Recall letter dated September 21, 2012, to all affected customers. The letter identifiedthe product, the problem, and the action to be taken by the customer. Customers were instructed to locate and quarantine the affected product. Customers were to return the affected product along with the completed Inventory Return Certificate Form. If product was further distributed the Recall Letter should be forwarded to their customers. Product was to be returned to USA accounts - Zimmer Product Service Department, 1777 West Center St. Warsaw, IN 46580. If product has been implanted, affected surgeons will be notified. For questions regarding this recall call 574-372-4807.

Recall details

Recall number
Z-0437-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 21, 2012
Posted by the FDA
Nov 26, 2012
Recalling firm
Zimmer, Inc.
Quantity
123 worldwide (33 USA)
Product code
JWH
FDA submissions
K872379
Distribution
Worldwide Distribution - USA including AZ,CA, FL, IA, IL, IN, MO, NE, NJ, NY, OH, PA, WA. Internationally to Thailand, Canada, Germany, France, UK, Hungary, Netherlands, Russian Fed, and Sweden,

Product description

NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; collagen 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; salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

Code information (models, lots, serial numbers)

Catalog 00-5986-047-02, lots 62049114 and 62045235.

Other devices under the same FDA submission

21 devices cleared under K872379 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page