I.t.s. Gmbh Autal 28 Lasnitzhohe Austria: Plate, Fixation, Bone
I.T.S. GmbH is recalling several clavicle (collarbone) plates used in bone fixation surgery because new MRI safety testing showed these devices heat up more than expected during MRI scans under certain conditions. The recall affects clavicle plates with specific model numbers that were distributed nationwide across the United States. Patients who received these implants should be aware of the updated heating risk if they need an MRI procedure.
- Recalling firm
- I.T.S. GmbH Autal 28 Lasnitzhohe Austria
- Product
- Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
- Reason
- Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-23
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/acea1229-b4d7-4977-982b-8dcd42c16db1