# FDA recall Z-1241-2018

> **Encore Medical, Lp** · Class II · device recall initiated 2018-01-30.

## Product

AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP  Orthopedic surgical instrument.    Product Usage:  The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.

## Reason for recall

Broken or missing screws and retaining clips.  This may be due to screw tolerance and material strength of the trial.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1241-2018
- **Recalling firm:** Encore Medical, Lp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-30
- **Report date:** 2018-04-04
- **Termination date:** 2023-05-30

- **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-1241-2018

## Citation

> AI Analytics. FDA recall Z-1241-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1241-2018. Source: US FDA. Licensed CC0.

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