Summary
The FDA issued a Class II for JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 by Biomet, Inc.. Reason: Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another.
Details
Source
Device Recall
External ID
Z-0477-2025
Action Date
2024-11-27
Status
Ongoing
Category
device
Product Description
JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
Lot/Code Info: 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
Quantity Affected: 691 (US); 2,045 (OUS)
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Singapore, Switzerland.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-21
Company
Warsaw, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 280 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Biomet, Inc. has 66 FDA actions in our database, including 60 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Biomet, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biomet, Inc. have FDA actions?
Biomet, Inc. has 66 FDA actions in our database, including 60 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0477-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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