# FDA recall Z-2331-2021

> **Encore Medical, LP** · Class II · device recall initiated 2021-06-28.

## Product

AltiVate Anatomic Shoulder System for the following Part Numbers:    1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part #  520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000

## Reason for recall

Complaints have been received concerning the humeral stem failing to mate with the broach handles for a  shoulder device. This could result in delay of procedure or revision surgery.

## Distribution

US: AL,AR,AZ,CA,CO,FL,GA,HI,IL,IN,KY,LA,MD,ME,MI,MN,MO,MS,MT,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,TN,TX,UT,VA,WA,WV    OUS: N/A

## Key facts

- **Recall number:** Z-2331-2021
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-28
- **Report date:** 2021-09-01

- **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-2331-2021

## Citation

> AI Analytics. FDA recall Z-2331-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2331-2021. Source: US FDA. Licensed CC0.

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