ITS Recalls 70 Olecranon Plates Over MRI RF Heating Risk (2026)

How to identify if yours is affected

1. Check the article numbers on the device packaging: 21112-7, 21114-5, 21113-9, 21111-6, 21111-8, 21111-12.
2. Check for listed lot numbers corresponding to the two article-number groups.
3. Verify if your device matches the recalled models.

Where to find product info

FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1597-2026 and the manufacturer's recall notice.

What timeline to expect

Refunds or replacements will be coordinated by ITS through the recall process and communicated via recall notices.

If the manufacturer is unresponsive

• Escalate to the FDA recall process or contact the device manufacturer for guidance.
• Consult your healthcare provider if you have concerns about MRI safety with implants.

How to prevent similar issues

• Before future implants, confirm MR safety compatibility with MRI, review IFU for MRI conditions.
• Maintain an updated medical device record with model/article numbers and lot numbers.
• Seek manufacturers' safety updates prior to MRI scheduling if you have implanted hardware.

Documentation advice

Keep a copy of the recall notice, document device article numbers and lot numbers, save correspondence from ITS or your provider, and record any MRI encounters.