# FDA recall Z-1550-2026

> **Medartis AG** · Class II · device recall initiated 2026-01-09.

## Product

Brand Name: APTUS  Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg  Model/Catalog Number: A-5850.16/1  Software Version: Not applicable.  Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.  Component: Not applicable.

## Reason for recall

Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

## Distribution

Worldwide - US  Nationwide distribution in the states of Indiana and Pennsylvania and the countries of Austria, Belgium, Switzerland, Czech Republic, Germany, Spain, Finland, France, Israel, Italy, Japan, and Poland.

## Key facts

- **Recall number:** Z-1550-2026
- **Recalling firm:** Medartis AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-09
- **Report date:** 2026-03-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Basel Town, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1550-2026

## Citation

> AI Analytics. FDA recall Z-1550-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1550-2026. Source: US FDA. Licensed CC0.

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