# FDA recall Z-1604-2026

> **I.T.S. GmbH** · Class II · device recall initiated 2026-01-23.

## Product

I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers.  1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4.   2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6.   3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.

## 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

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.

## Key facts

- **Recall number:** Z-1604-2026
- **Recalling firm:** I.T.S. GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-23
- **Report date:** 2026-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lasnitzhohe, Austria

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1604-2026

## Citation

> AI Analytics. FDA recall Z-1604-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1604-2026. Source: US FDA. Licensed CC0.

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