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U.S. Department of Health and Human Services

Class 2 Device Recall JuggerLoc/ToggleLoc

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 Class 2 Device Recall JuggerLoc/ToggleLocsee related information
Date Initiated by FirmOctober 21, 2024
Date PostedNovember 15, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0477-2025
Recall Event ID 95597
Product Classification Kit, surgical instrument, disposable - Product Code KDD
ProductJuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
Code Information UDI-DI 00880304857254 Lots 0002446326 0002446333 0002452241 0002453378 0002467342 0002476076 0002476077 0002476078 0002481506 0002481724 0002486540 0002486541 0002490256 0002493107 0002496066 0002497715 0002497716 0002500871 0002500872 0002504026 0002504027 0002504031 0002504032 0002504033 0002504034 0002504035 0002504036 0002504037 0002504546 0002513868 0002517982 0002517983 0002527929 0002527931 0002528042 0002528043 0002528044 0002528045 0002544040 0002592614 0002592615 0002592616 0002592617 0002592618 0002602484 0002602487 0002602490 0002614121 0002614122 0002614123 0002624306
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.
FDA Determined
Cause 2		Process control
ActionPending
Quantity in Commerce691 (US); 2,045 (OUS)
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Singapore, Switzerland.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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