Quick Facts at a Glance
- Recall Date
- January 23, 2026
- Hazard Level
- HIGH
- Brand
- I.T.S. GmbH
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Pelvic Reconstruction System PRS components (Fixation Screw and Spike short)
- Model numbers
- 1. Article Number (Lot Number): 70312 (26/F65133). 2. Article Number (Lot Number): 70314 (86/619736).
- Sold at
- Unknown
- 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
Pelvic Reconstruction System implants are used in complex pelvic surgeries to restore stability. The two components affected are part of the PRS and are distributed in the US through medical channels.
Why This Is Dangerous
MRI procedures can heat tissue when devices interact with RF energy. The recalled PRS components exhibit higher RF-induced temperature increases than described in the IFU, creating a risk during MRI.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Patients with these implants may need MRI avoidance or modification until cleared. Healthcare facilities should implement recall procedures to identify affected devices and coordinate replacements or monitoring.
Practical Guidance
How to identify if yours is affected
- Identify if your device is PRS with article numbers 70312 or 70314.
- Check lot numbers: 70312 corresponds to 26/F65133; 70314 corresponds to 86/619736.
- If affected, stop using the device immediately and contact a healthcare provider for instructions.
- Do not perform MRI or keep the device in MRI environments until cleared by the manufacturer.
- Follow the manufacturer's recall instructions and await further guidance on refunds or replacements.
Where to find product info
Recall details are available on the FDA enforcement page linked in the recall notice and through ITS GmbH communications.
What timeline to expect
Timeline for refunds or replacements is not specified in the notice. Await recall communications for next steps.
If the manufacturer is unresponsive
- Escalate with the healthcare provider or hospital risk management.
- File a report with FDA recall channels if the manufacturer does not respond timely.
How to prevent similar issues
- Ask vendors for MRI-compatibility data before implanting hardware.
- Verify MRI labeling and IFU for implanted devices before MRI procedures.
- Maintain up-to-date recall monitoring for implanted devices.
Documentation advice
Document all recall communications, keep device labeling and lot numbers, and retain any hospital correspondence related to the recall.
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Product Details
Model numbers: 70312 Fixation Screw and 70314 Spike short. Lot numbers: 70312 with 26/F65133; 70314 with 86/619736. Distribution: US nationwide, states include AL, AZ, BVI, 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, WV, WA. Sold in US nationwide distribution. Price not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Article numbers 70312 and 70314
- Lot numbers 26/F65133 and 86/619736
- MRI safety testing revealed higher RF-induced temperatures under certain MRI conditions
- Recall status ACTIVE as of 2026-04-01
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Safety Guide
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