# FDA recall Z-1605-2026

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

## Product

FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers.     1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30.     2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34.     3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24.     4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6.     5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME.     6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483.     7. FLS - Foot Locking Plates Sy

## 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-1605-2026
- **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-1605-2026

## Citation

> AI Analytics. FDA recall Z-1605-2026. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-1605-2026. Source: US FDA. Licensed CC0.

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