# FDA recall Z-1730-2022

> **Exactech, Inc.** · Class II · device recall initiated 2022-08-11.

## Product

GXL acetabular liners, orthopedic hip implant component.   Product Line Numbers:    a. 	NOVATION CONSTRAINED LINER 28MM ID GROUP 1, 	REF 134-28-41  b. 	NOVATION CONSTRAINED LINER 32MM ID GROUP 2, 	REF 134-32-42  c. 	NOVATION CONSTRAINED LINER 36MM ID GROUP 3, 	REF 134-36-43  d. 	NOVATION CONSTRAINED LINER 36MM ID GROUP 4, 	REF 134-36-44  e. 	NOVATION CONSTRAINED LINER 36MM ID GROUP 5, 	REF 134-36-45

## Reason for recall

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

## Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN

## Key facts

- **Recall number:** Z-1730-2022
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-11
- **Report date:** 2022-09-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1730-2022

## Citation

> AI Analytics. FDA recall Z-1730-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1730-2022. Source: US FDA. Licensed CC0.

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