Zimmer Manufacturing B.V.: Medical Device Recall in 2015 - (Recall #: Z-0449-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty.

Product Classification:

Class II

Date Initiated: December 2, 2015

Date Posted: December 30, 2015

Recall Number: Z-0449-2016

Event ID: 72729

Reason for Recall:

Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264

Status: Terminated

Product Quantity: 179

Code Information:

lot #62460264

Distribution Pattern:

US Distribution and the country of Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated