Recall Z-2619-2025 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Biomet, Inc.
Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
| Date | Sep 23, 2025 (initiated Sep 9, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 9/9/25 was sent to customers. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the recall notice and ensure documentation. 4. Complete Attachment 1 Certificate of A |
| Quantity | 40 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110879 | BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR Biomet Sports Medicine, Aug 19, 2011 |