# FDA recall Z-0282-2024

> **Encore Medical, LP** · Class II · device recall initiated 2023-09-25.

## Product

RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.

## Reason for recall

Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.

## Distribution

US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA

## Key facts

- **Recall number:** Z-0282-2024
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-25
- **Report date:** 2023-11-15

- **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-0282-2024

## Citation

> AI Analytics. FDA recall Z-0282-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0282-2024. Source: US FDA. Licensed CC0.

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