# FDA recall Z-1729-2022

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

## Product

GXL acetabular liners, orthopedic hip implant component.  Product Line Numbers:    a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51  b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52  c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, REF 130-36-53  d. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 4 CUPS, REF 130-36-54  e. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 5 CUPS, REF 130-36-55  f. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 3 CUPS, REF 136-32-53  g. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 4 CUPS, REF 136-32-54  h. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 5 CUPS, REF 136-32-55  i. NOVATION GXL LINER, +5LAT, 28MM G1-48/50MM CUPS, REF 136-28-51  j. NOVATION GXL LINER, +5LAT, 32MM G1-48/50MM CUPS, REF 136-32-51  k. NOVATION GXL LINER, +5LAT, 32MM G2-52/54MM CUPS, REF 136-32-52  l. NOVATION GXL LINER, +5LAT, 36MM G2-52/54MM CUPS, REF 136-36-52  m. NOVATION GXL LINER, +5LAT, 36MM G3-56/58MM CUPS, REF 136-36-53  n. NOVATION GXL LINER, +5LAT

## 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-1729-2022
- **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-1729-2022

## Citation

> AI Analytics. FDA recall Z-1729-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1729-2022. Source: US FDA. Licensed CC0.

---

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