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U.S. Department of Health and Human Services

Class 2 Device Recall JUGGERKNOT

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  Class 2 Device Recall JUGGERKNOT see related information
Date Initiated by Firm June 30, 2017
Create Date March 14, 2018
Recall Status1 Terminated 3 on April 13, 2018
Recall Number Z-0993-2018
Recall Event ID 79242
510(K)Number K131684  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product JUGGERKNOT 2.9MM 2 #2 MB

Product Usage:
For use in hip arthroplasty
Code Information Part number: 912050 Lot number: 221890
Recalling Firm/
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
Manufacturer Reason
for Recall
For soft tissue fixation
FDA Determined
Cause 2
Packaging process control
Action On June 2, 2017 an URGENT Medical Recall Letter was issued to customers regarding affected product(s). The letter requests customers to review the content and notify affected personnel of the recall. Assist the sales representative in quarantining affected product, which will be removed and returned to recalling firm and then replaced. All customers who may have received product from distributors are to be notified. Questions or concerns can be directed to 1-574-372-4847.
Quantity in Commerce 50
Distribution US in the state of Texas
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 = LZO and Original Applicant = BIOMET, INC.