Zimmer, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1935-2014)

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 4+. 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-1935-2014

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 4+, includes the following Lot numbers: 61424996 61459959 61475129 61538052 61563971 61573791 61573792 61592090 61627207 61685463 61721674 61774165 61863139 61870152 61934692 61935096 61979044 61979045 62020278 62064940 62091727 62214673 62251567 62251568 62319307 62337924 62369795 62401020 62423841 62436412 62471736 62602816 62646169

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