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U.S. Department of Health and Human Services

Class 2 Device Recall Juggerknotless Soft Anchors

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  Class 2 Device Recall Juggerknotless Soft Anchors see related information
Date Initiated by Firm October 10, 2013
Date Posted November 19, 2013
Recall Status1 Terminated 3 on July 16, 2014
Recall Number Z-0364-2014
Recall Event ID 66639
510(K)Number K123485  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product Juggerknotless Drill Bit, REF 110003173,
Sterile, Single Use

Product Usage:
The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
Code Information Catalog:110003173, Lot 127480, 185420, 233500, 233520
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-267-6639
Manufacturer Reason
for Recall		 Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion.
FDA Determined
Cause 2		 Device Design
Action Biomet sent an Urgent Medical Device Recall Notice letter dated October 10, 2013 to all consignees. The letter identified the affected product, reason for recall, and actions to be taken. The letter stated customers will be contacted on an individual basis in an attempt to reconcile the affected product. Customers were directed to locate and remove implicated devices and fax a copy of the response form to 574-372-1683 prior to returning product. For questions call 574-372-1570.
Quantity in Commerce 25
Distribution USA Nationwide Distribution in the states of VA, CA, Ky, and IN
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 SPORTS MEDICINE
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