Zimmer, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0461-2014)

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 Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.

Product Classification:

Class II

Date Initiated: November 19, 2013

Date Posted: December 18, 2013

Recall Number: Z-0461-2014

Event ID: 66809

Reason for Recall:

This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadvertently utilized during surgery, resulting in a delay. The associated implants would not be available due to the previous recall.

Status: Terminated

Product Quantity: 638 units

Code Information:

Part Number 00-5971-020-09

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated