# FDA recall Z-0007-2023

> **Zimmer, Inc.** · Class II · device recall initiated 2022-08-25.

## Product

G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty

## Reason for recall

The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.

## Distribution

Domestic distribution US nationwide.

## Key facts

- **Recall number:** Z-0007-2023
- **Recalling firm:** Zimmer, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-25
- **Report date:** 2022-10-12

- **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-0007-2023

## Citation

> AI Analytics. FDA recall Z-0007-2023. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-0007-2023. Source: US FDA. Licensed CC0.

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