Zimmer, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0437-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 21, 2012

Date Posted: December 5, 2012

Recall Number: Z-0437-2013

Event ID: 63544

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

Status: Terminated

Product Quantity: 123 worldwide (33 USA)

Code Information:

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

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,

Voluntary or Mandated:

Voluntary: Firm initiated