Quick Facts at a Glance
- Recall Date
- September 9, 2025
- Hazard Level
- HIGH
- Brand
- Biomet
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Biomet
- Product type
- Soft Suture Anchors
- Model numbers
- 912080, UDI-DI: 00880304520950, Lot Number 0002713620
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 9, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Biomet, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
JuggerKnot Mini Soft Anchors are surgical implants used in orthopedic procedures to secure soft tissue to bone.
Why This Is Dangerous
The packaging labeling mismatch could lead to incorrect device use or selection, posing patient safety risks.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinicians must verify the correct device against packaging to avoid inappropriate implants. The recall may require re-labeling or replacement in surgical inventories.
Practical Guidance
How to identify if yours is affected
- 1) Check carton label against device model 912080.
- 2) Verify the UDI-DI 00880304520950 on the packaging.
- 3) If mismatch is found, set aside and contact Biomet for instructions.
- 4) Follow recall instructions in the official notice.
Where to find product info
UDI-DI on packaging, device labeling, and lot number 0002713620.
What timeline to expect
Recall resolution timelines vary; expect guidance from Biomet within weeks.
If the manufacturer is unresponsive
- Contact your healthcare facility's risk management or surgeon.
- Escalate to FDA MedWatch if Manufacturer is unresponsive.
How to prevent similar issues
- Verify model and UDI before use or implantation.
- Procure only from authorized distributors.
- Request and review recall notices promptly for all implants.
- Keep records of device lot numbers and UPCs.
Documentation advice
Keep the recall notice and any correspondence. Photograph labeling and packaging. Log device lot numbers and UDI codes for inventory records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model/Catalog Number: 912080 UDI-DI: 00880304520950 Lot Number: 0002713620 Distribution: US Nationwide Sold at: Unknown Recall Date: 2025-09-09 Manufacturer: Biomet Classification: Class II
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distribution: US Nationwide
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
