Zimmer, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1939-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.

Product Classification:

Class II

Date Initiated: May 19, 2014

Date Posted: July 9, 2014

Recall Number: Z-1939-2014

Event ID: 68457

Reason for Recall:

Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Status: Terminated

Product Quantity: 41,180 total

Code Information:

Size 8, includes the following Lot numbers: 370321 37213648 37216196 61424999 61543980 62029931 62390069

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated