Recall Z-1598-2026
I.T.S. GmbH · initiated January 23, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.
Codes / lots: 1. Article Number (Lot Numbers): 21604-6 (643/052301, 643/0652, 643/092201), 21604-9 (643/032311, 643/062308, 643/062309, 643/112310, 643/122201). 2. Article Number (Lot Numbers): 21605-11 (643/072314, 643/102207), 21605-6 (643/0654, 643/072306, 643/072316, 643/072338, 643/102208, 643/102212, 643/102217, 643/112306, 643/122202), 21605-9 (643/0643, 643/0662, 643/072307, 643/072339, 643/112309, 643/122203). 3. Article Number (Lot Numbers): 21105-6 (86/876787), 21105-8 (86/876788). 4. Article Number (Lot Numbers): 21104-4 (679/052234, 679/082305, 86/036334), 21104-5 (679/0722101, 679/082306, 86/036335), 21104-6 (679/012307, 86/876760), 21104-7 (679/082307, 86/036336, 86/876781), 21104-8 (679/082308, 86/876783), 21104-9 (86/876904). 5. Article Number (Lot Numbers): 21101-5 (86/876637), 21101-6 (679/121605, 00/1105-12, 26/F41923, 86/876638, 86/903610), 21101-7 (770/201905, 00/0518-06, 679/042303, 86/876640), 21101-8 (86/876721, 679/062224), 21101-9 (679/122264, 86/876727), 21101-11 (86/876633), 21101-13 (86/876635). 6. Article Number (Lot Numbers): 21102-6 (770/201905). 7. Article Number (Lot Numbers): 21103-8 (679/092216), 21103-9 (679/062215, 86/876758), 21103-10 (679/092219…
Reason for recall
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
FDA-determined cause: No Marketing Application
Action taken
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 devices, and arrange for the return of specific originally packaged items - base plates and screws in surgery trays. Other outlined products can continue to be used upon confirmation from ITS. Consignees were also instructed to complete and return the response form. Distributors were instructed to continue to immediately halt product distribution from the U.S. office to sales groups and hospitals, remove the outdated paper IFU from packaging and add the eIFU symbol to product labeling to implement the updated IFU provided electronically - see annex "F-7.5.5-3-US_IFU_non-sterile_Rev00_DRAFT". Paper IFUs will be made available upon request. They were also requested to assist in notification of hospitals.
Details
- Recall number
- Z-1598-2026
- Initiated
- January 23, 2026
- Posted by FDA
- March 20, 2026
- Product code
- HRS – Plate, Fixation, Bone
- Quantity
- 510 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.
- Recalling firm
- I.T.S. GmbH, Lasnitzhohe
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1592-2026 Class II | Volar Radius Plate with Angular Stability with the following description: Radius Plate…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1593-2026 Class II | Claviculaplate with Angular Stability, with the below descriptions and associated…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1594-2026 Class II | Brand Name: Humeral Head Plate with Angular Stability, with the following description:…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1595-2026 Class II | FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1596-2026 Class II | Pilonplate with Angular Stability, with the below descriptions and corresponding article…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1597-2026 Class II | Olecranonplate with Angular Stability with the below descriptions and corresponding…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1599-2026 Class II | I.T.S. Screw System with the below descriptions and corresponding article numbers. 1.…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1600-2026 Class II | Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1601-2026 Class II | I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1602-2026 Class II | Distal Humeral Plates with Angular Stability with the below descriptions and…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1603-2026 Class II | I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1604-2026 Class II | I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1605-2026 Class II | FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1606-2026 Class II | HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1607-2026 Class II | HLS - Hand Locking Plates System with the below descriptions and corresponding article…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1608-2026 Class II | Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |