# FDA recall Z-0673-2022

> **Biomet, Inc.** · Class II · device recall initiated 2022-01-07.

## Product

Comprehensive Shoulder System Primary Shoulder Stem,  Micro Length, Porous Plasma, 18 MM, 55 MM Long  Item Number: 113618

## Reason for recall

The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.

## Key facts

- **Recall number:** Z-0673-2022
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-07
- **Report date:** 2022-03-02
- **Termination date:** 2023-04-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0673-2022

## Citation

> AI Analytics. FDA recall Z-0673-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0673-2022. Source: US FDA. Licensed CC0.

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