# FDA recall Z-1733-2022

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

## Product

GXL acetabular liners, orthopedic hip implant component.   Product Line Numbers:    a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM  SZ 42, REF 106-22-42;   b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM  SZ 44, REF 106-22-44;   c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM  SZ 46, REF 106-22-46;   d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM  SZ 48, REF 106-22-48;   e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM  SZ 50, REF 106-22-50;   f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM  SZ 52, REF 106-22-52;   g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM  SZ 54, REF 106-22-54;   h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM  SZ 48, REF 106-28-48;   i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM  SZ 50, REF 106-28-50;   j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM  SZ 52, REF 106-28-52;   k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM  SZ 54, REF 106-28-54;   l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM  SZ 56, REF 106-28-56;   m. ALL POLYETHYL

## 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-1733-2022
- **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-1733-2022

## Citation

> AI Analytics. FDA recall Z-1733-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1733-2022. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*