CLASS II ONGOING Device recall · Reported 1 Apr 2026 · FDA Enforcement Report
HCS - Headless Compression Screw System recalled by I.T.S
I.T.S is recalling HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated, distributed nationwide in the US. The recall was initiated on 23 Jan 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1606-2026
- FDA event ID
- 98341
- Recalling firm
- I.T.S, Lasnitzhohe
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Jan 2026
- FDA classified
- 20 Mar 2026
- Reported
- 1 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Temperature Abuse
- Device type
- Heart & Vascular Devices
Timeline
| 23 Jan 2026 | Recall initiated by company | |
| 20 Mar 2026 | Classified by FDA | +56 days |
| 1 Apr 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiMontanaNebraskaNew Jersey
Questions about this recall
Why was it recalled?
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Which lots are affected?
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).
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
16 other products · FDA event 98341More recalls from I.T.S
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pelvic Reconstruction System (PRS) recalled by I.T.S | I.T.S | Temperature Abuse | Nationwide |
| Device | CLASS II | Volar Radius Plate with Angular Stability recalled | I.T.S | Temperature Abuse | Nationwide |
| Device | CLASS II | Pilonplate with Angular Stability recalled | I.T.S | Temperature Abuse | Nationwide |
| Device | CLASS II | FR.O.H. Calcaneus Repair System recalled by I.T.S | I.T.S | Temperature Abuse | Nationwide |
| Device | CLASS II | I.T.S. DUL (Distal Ulna Locking) System and UOL recalled | I.T.S | Temperature Abuse | Nationwide |
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