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