# FDA recall Z-3021-2020

> **Encore Medical, LP** · Class II · device recall initiated 2020-08-07.

## Product

RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044

## Reason for recall

Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the  patient experiencing dislocation resulting in revision surgery.

## Distribution

Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA

## Key facts

- **Recall number:** Z-3021-2020
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-08-07
- **Report date:** 2020-10-07

- **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-3021-2020

## Citation

> AI Analytics. FDA recall Z-3021-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-3021-2020. Source: US FDA. Licensed CC0.

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