Zimmer, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0480-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. 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.

Product Classification:

Class II

Date Initiated: October 31, 2013

Date Posted: December 18, 2013

Recall Number: Z-0480-2014

Event ID: 66714

Reason for Recall:

Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be oversized by .010.

Status: Terminated

Product Quantity: 128 units

Code Information:

00-5980-037-02; lot 6228417

Distribution Pattern:

Worldwide Distribution - USA (nationwide) including the states of CA, IN, OH, GA, WI, IA, NE, NJ, PA, NY, MD, NC, AZ, NM, TX, CO, IL, AL, MI, WA, FL and KS, and the countries of China, Japan and Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated