Summary
The FDA issued a Class II for Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 by Biomet, Inc.. Reason: The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices..
Details
Source
Device Recall
External ID
Z-2619-2025
Action Date
2025-10-01
Status
Ongoing
Category
device
Product Description
Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
Lot/Code Info: UDI-DI: 00880304520950; Lot Number 0002713620
Quantity Affected: 40
Reason for Recall
The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-09
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 152 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-2619-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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