Quick Facts at a Glance
- Recall Date
- January 23, 2026
- Hazard Level
- HIGH
- Brand
- I.T.S. GmbH
- 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
- I.T.S. GmbH
- Product type
- Olecranon Plate with Angular Stability
- Model numbers
- 1 Article number (Lot Numbers): 21112-7 (643/0549), 21114-5 (643/032301, 643/042303, 643/042304, 643/0618, 643/102211, 643/112304), 21113-9 (643/072320). 2. Article number (Lot Numbers): 21111-6 (643/032306 +4 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 23, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact I.T.S. GmbH or your healthcare provider for instructions. Notification method: E-Mail
About This Product
Olecranon plates are orthopedic implants used to fix fractures of the elbow. They are surgically implanted and intended to stabilize the olecranon during healing.
Why This Is Dangerous
RF heating during MRI can cause temperature increases at the implant site. This can pose a risk to surrounding tissue during MRI scans under certain conditions.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Health care providers and patients must avoid MRI exposure with these implants until further notice. Impact includes potential procedure delays and need for implant assessment.
Practical Guidance
How to identify if yours is affected
- Check the article numbers on the device packaging: 21112-7, 21114-5, 21113-9, 21111-6, 21111-8, 21111-12.
- Check for listed lot numbers corresponding to the two article-number groups.
- 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.
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Product Details
Product: Olecranon Plate with Angular Stability. Article Numbers: 21112-7, 21114-5, 21113-9; 21111-6, 21111-8, 21111-12. Quantity: 70 units. Distribution: US nationwide. States listed include AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, VI, WV. Recall date: 2026-01-23. Status: Active.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Hazard: MRI RF heating risk under certain conditions
- Active recall as of 2026-01-23
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Safety Guide
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