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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Juggerknot in Guide Punch

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  Class 2 Device Recall Biomet Juggerknot in Guide Punch see related information
Date Initiated by Firm August 14, 2012
Date Posted September 17, 2012
Recall Status1 Terminated 3 on April 18, 2013
Recall Number Z-2399-2012
Recall Event ID 62391
Product Classification Punch, surgical - Product Code LRY
Product JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM.

The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
Code Information REF. 912064 LOT 121040, 497540, 839530
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Claudia Candito
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		 Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.
FDA Determined
Cause 2		 Device Design
Action Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated August 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Response Form was included for customers to complete and return via fax to 574-372-1683. Questions related to the recall should be directed to 574-371-3758, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in Commerce 62
Distribution Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA.
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.
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