Screw Recall: ITS Headless Compression System
Announced 2026-04-01 · FDA
ITS recalls two Pelvic Reconstruction System components—the Fixation Screw (Article 70312) and Spike short (Article 70314)—because updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than the IFU previously reflected. The recall covers 11 units distributed nationwide in the United States, with recall numbers 70312 (26/F65133) and 70314 (86/619736). No corrective action is listed in the record.
| Brand | I.T.S. GmbH |
|---|---|
| Product | Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314. |
| Reason | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| Severity | moderate |
| Units affected | 623 |
| Distribution | US Nationwide distribution in the states of 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, W. |
| Agency | FDA |
| Recall / campaign no. | 1. Article Number (Lot Number): 70312 (26/F65133). 2. Article Number (Lot Number): 70314 (86/619736). |
WHAT YOU SHOULD DO
- Verify whether you have the affected components (70312 or 70314) in your medical device.
- Consult your surgeon or radiology team about MRI safety for this device and any upcoming imaging.
- Do not undergo MRI unless your clinician approves based on the updated safety information.
- Monitor FDA and ITS communications for recall updates and follow any provided instructions.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.