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U.S. Department of Health and Human Services

Class 2 Device Recall Juggerknot Long Flex Drill Bit

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  Class 2 Device Recall Juggerknot Long Flex Drill Bit see related information
Date Initiated by Firm August 03, 2018
Create Date September 26, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall Number Z-3252-2018
Recall Event ID 80918
510(K)Number K110145  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992
Code Information Lot Numbers:  053940, 545740, 067490, 664610, 165770, 676180, 165830, 688250, 415590, 860050
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact SAME
574-372-1687
Manufacturer Reason
for Recall		 Expiration date incorrectly listed on the label
FDA Determined
Cause 2		 Device Design
Action Zimmer notified distributors on 8/3/18 distributors notified via email. Hospital risk managers, as well as distributors with product, notified via Fed'X. The letter identifies the issue and their responsibilities, locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory. Product to be returned to Zimmer Biomet. Question customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday or to :CorporateQuality.PostMarket@zimmerbiomet.com
Quantity in Commerce 217 units
Distribution AZ CO FL FL GA LA MA MA MO NY SC TX
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 = MBI and Original Applicant = BIOMET, INC.
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