Recall Z-1602-2026 ยท HRS Plate, Fixation, Bone
I.T.S. GmbH
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351
| Date | Mar 20, 2026 (initiated Jan 23, 2026) |
| Status | Open, Classified |
| Reason | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| Root cause | No Marketing Application |
| Action | ITS initially notified its importer/distributor on about 01/23/2026 via email. Instructions were to cease distribution, and further information will be provided. An additional notification was sent to distributors and consignees on about 02/04/2026 via email. Instructions included to ensure any IFU different to the provided one is removed from systems and/or destroyed, notify clinical staff managing patients with implants, contact I.T.S. GmbH for any questions or to discuss proper scanning conditions for implanted devices in the interim while they work on labeling and IFU updates for the devi |
| Quantity | 12,059 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080184 | DISTAL HUMERAL PLATES WITH ANGULAR STABILITY I.T.S. Implantat-Technologie-Systeme GmbH, Mar 26, 2008 |