# FDA recall Z-2618-2026

> **Medacta Usa Inc** · Class II · device recall initiated 2026-04-30.

## Product

Short Monobloc Stem Broaches, Size/REF:  7/04.01.10.0970,  8/04.01.10.0971,  9/04.01.10.0972,  10/04.01.10.0973,  11/04.01.10.0974,  12/04.01.10.0975,  13/04.01.10.0976,  14/04.01.10.0977,  15/04.01.10.0978,  16/04.01.10.0979    Part of Medacta Shoulder System

## Reason for recall

Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.

## Distribution

US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.

## Key facts

- **Recall number:** Z-2618-2026
- **Recalling firm:** Medacta Usa Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-30
- **Report date:** 2026-07-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2618-2026

## Citation

> MORVS. FDA recall Z-2618-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2618-2026. Source: US FDA. Licensed CC0.

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