FDA Enforcement Class II Ongoing

Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080

Recall: Z-2619-2025 · Reported October 1, 2025

Enforcement

Recall Number
Z-2619-2025
Event ID
97570
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Biomet, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
October 1, 2025
Initiation Date
September 9, 2025
Classification Date
September 23, 2025
Address
56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

Description

Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080

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.

Code Info

UDI-DI: 00880304520950; Lot Number 0002713620

Distribution

US Nationwide distribution.

Quantity

40