# FDA recall Z-0625-2024

> **Encore Medical, LP** · Class II · device recall initiated 2023-10-05.

## Product

Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797

## Reason for recall

Mislabeling

## Distribution

US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.

## Key facts

- **Recall number:** Z-0625-2024
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-10-05
- **Report date:** 2024-01-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0625-2024

## Citation

> AI Analytics. FDA recall Z-0625-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0625-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*