# FDA recall Z-1259-2018

> **Encore Medical, Lp** · Class II · device recall initiated 2018-01-29.

## Product

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500    Product Usage:  The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

## Reason for recall

It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1259-2018
- **Recalling firm:** Encore Medical, Lp
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2018-01-29
- **Report date:** 2018-04-04

- **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-1259-2018

## Citation

> AI Analytics. FDA recall Z-1259-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1259-2018. Source: US FDA. Licensed CC0.

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