Home / Recalls / I.T.S. GmbH / Z-1606-2026

Z-1606-2026 Class II Ongoing

Recalled by I.T.S. GmbH — Lasnitzhohe

FDA device recall Z-1606-2026 was initiated by I.T.S. GmbH on January 23, 2026 and is designated Class II. 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). The recall status is ongoing. Affected quantity: 623 units.

Recall Details

Product Type
Devices
Report Date
April 1, 2026
Initiation Date
January 23, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
623 units

Product Description

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

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).

Distribution Pattern

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.

Code Information

Article Number (Lot Numbers): 31207-10 (679/112002), 31207-12 (679/092133, 679/102343, 679/112006), 31207-14 (679/102050), 31207-16 (679/102345, 679/102049), 31207-18 (679/0323110, 679/102355, 679/112001), 31207-20 (679/0323111, 679/102051, 679/102356), 31207-24 (679/102028), 31207-26 (679/112008), 31207-28 (679/112009), 31207-30 (679/0323140, 86/483377), 31257-12 (679/081904), 31257-14 (679/042323, 679/081905), 31257-16 (679/042324), 31257-18 (679/112308, 679/022128), 31257-20 (679/022123, 679/042326, 679/112321), 31257-22 (679/022124, 679/042327, 679/112325), 31257-24 (679/022125, 679/112326), 31257-28 (679/022130, 679/052306), 31257-30 (679/022131), 31307-18 (679/061907), 31307-32 (679/062285), 31307-34 (679/062286), 31307-36 (679/062287), 31307-38 (679/032118), 31358-30 (26/F67790), 31437-30 (679/071916), 31437-38 (679/071918), 31437-40 (679/032406, 679/071903), 31437-50 (679/071920), 31757-100 (35/51892), 31757-120 (86/320792), 31757-45 (86/320793), 31757-80 (26/F55872), 31757-85 (26/F55873), 31757-90 (26/F55874).

Other recalls by I.T.S. GmbH

  • Z-1600-2026 Class II — Pelvic Reconstruction System (PRS) with the below descriptions and corresponding (January 23, 2026)
  • Z-1608-2026 Class II — Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the (January 23, 2026)
  • Z-1594-2026 Class II — Brand Name: Humeral Head Plate with Angular Stability, with the following descri (January 23, 2026)
  • Z-1603-2026 Class II — I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corre (January 23, 2026)
  • Z-1601-2026 Class II — I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions a (January 23, 2026)
  • Z-1604-2026 Class II — I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System (January 23, 2026)
  • Z-1592-2026 Class II — Volar Radius Plate with Angular Stability with the following description: Radius (January 23, 2026)
  • Z-1607-2026 Class II — HLS - Hand Locking Plates System with the below descriptions and corresponding a (January 23, 2026)
  • Z-1602-2026 Class II — Distal Humeral Plates with Angular Stability with the below descriptions and cor (January 23, 2026)
  • Z-1598-2026 Class II — I.T.S. Straight Plate with Angular Stability with the below descriptions and cor (January 23, 2026)

FDA data resources