The Recall Desk
HighFDA (Devices)·Z-1734-2022·Announced 2022-09-21

GXL Acetabular Liners Packaging Defect May Cause Accelerated Wear

Exactech GXL acetabular hip implant liners in non-conforming bags may experience accelerated wear. Approximately 7,946 devices were distributed worldwide. No injuries have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II recall addresses a risk-of-harm product (orthopedic joint implant) with no reported injuries. The non-conforming packaging causing accelerated wear in a critical structural component meets the rubric criterion for Score 3: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Exactech, Inc. is recalling certain GXL acetabular polyethylene liners used in hip replacement surgery. These orthopedic implant components were packaged in bags that do not conform to specifications.

The non-conforming bags may adversely impact the liners and contribute to accelerated wear of the device. Because acetabular liners are critical load-bearing components in hip implants, accelerated wear could potentially affect implant performance and longevity.

Approximately 7,946 affected devices were distributed worldwide. In the United States, distribution was nationwide. Outside the US, the liners were distributed to Argentina, Brazil, Chile, China, Colombia, Ecuador, Greece, Guatemala, India, Lebanon, Portugal, Puerto Rico, and Spain.

Patients who received hip implants containing GXL liners should contact their surgeon or healthcare provider with questions about their specific implant. Healthcare providers can identify affected devices by checking serial numbers and reference codes provided in the recall notice.

The recalled product

Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28
Manufacturer
Exactech, Inc.
Category
Medical Device — Orthopedic Implant / Hip Replacement Component
Hazard
  • accelerated-wear
  • packaging-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a. REF 130-28-05
  • GUDID 10885862021915
  • Serial Numbers: 693079
  • 693081
  • 693083
  • 693091
  • 793963
  • 793968
  • 793970
  • 793982
  • b. REF 130-28-06
  • GUDID 10885862021922
  • Serial Numbers: 618681
  • 618682
  • 618683
  • 618686
  • 618688
  • 618691
  • 618693
  • 618696

Distribution

Distributed nationwide across the United States.

Related recalls

Same category