# FDA recall Z-1173-2018

> **Biomet, Inc.** · Class II · device recall initiated 2018-02-28.

## Product

Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction

## Reason for recall

During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.

## Distribution

Distribution US Nationwide

## Key facts

- **Recall number:** Z-1173-2018
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-28
- **Report date:** 2018-04-04
- **Termination date:** 2020-08-11

- **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-1173-2018

## Citation

> AI Analytics. FDA recall Z-1173-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-1173-2018. Source: US FDA. Licensed CC0.

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