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.
FDA Recall Z-0437-2013 · Posted 2012-11-26
Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2012-09-21
Date Terminated2014-04-17
Product Quantity123 worldwide (33 USA)
Reason for Recall
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
Firm Action
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.
Root Cause
Process change control
Distribution Pattern
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,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.