ITS Fibula Plate PROlock with Angular Stability Recall Affects 869 Units (2026)

How to identify if yours is affected

1. Identify if your implant is one of the ITS Fibula Plate PROlock with Angular Stability article numbers listed in the recall.
2. Check with your surgeon or implant center to confirm the device model and MRI compatibility.
3. Review the FDA recall page for current instructions.

Where to find product info

Look in your surgical records, implant documentation, and the recall notice. The FDA enforcement page lists all affected article numbers.

What timeline to expect

Actions by hospitals may occur within weeks to months. Individual timelines depend on clinical circumstances and manufacturer guidance.

If the manufacturer is unresponsive

• Escalate to the hospital's medical device coordinator.
• Contact the recall sponsor and report lack of response to the appropriate regulatory body if needed.

How to prevent similar issues

• Before MRI, verify implant compatibility with MRI settings.
• Ask about MRI sequences and specific absorption rates when implants are present.
• Ask facilities to use implants with proven MRI compatibility for future devices.

Documentation advice

Keep copies of recall notices, communication with providers, and imaging decisions. Record dates, names, and actions taken.