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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer NexGen Precoat Stemmed Tibia

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  Class 2 Device Recall Zimmer NexGen Precoat Stemmed Tibia see related information
Date Initiated by Firm December 02, 2015
Create Date December 18, 2015
Recall Status1 Terminated 3 on September 16, 2016
Recall Number Z-0449-2016
Recall Event ID 72729
510(K)Number K933785  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product 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.
Code Information lot #62460264
Recalling Firm/
Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
Manufacturer 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
FDA Determined
Cause 2
Action An Urgent Medical Device Recall Letter, dated 12/2/15, was sent to the firm's consignees. All distributors will be notified via electronic mail. Hospital risk managers, surgeons, and distributors with product will be notified via courier.
Quantity in Commerce 179
Distribution US Distribution and the country of Thailand.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ZIMMER, INC.