The Recall Desk
HighFDA (Devices)·Z-1725-2022·Announced 2022-09-21

GXL Acetabular Hip Implant Liners Recalled Due to Packaging Defect

Exactech is recalling specific GXL acetabular hip implant liners due to non-conforming packaging that may cause accelerated device wear. The recall affects 1,017 devices distributed worldwide.

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 is a risk-of-harm medical device (hip implant) that may experience accelerated wear due to non-conforming packaging. No reported illnesses or injuries are mentioned in the source, and the hazard is theoretical, which per the rubric qualifies for a maximum score of 3.

Plain-English summary

Exactech, Inc. is recalling specific GXL acetabular polyethylene liner components used in hip replacement surgery. These implant components were packaged in non-conforming bags that may adversely affect device performance and lead to accelerated wear.

The recall involves 1,017 devices distributed worldwide, including across the United States and multiple international countries. Specific product line numbers and serial numbers have been identified for the affected devices.

Patients who received these hip implants should contact their surgeon or healthcare provider to determine whether their implant is affected and whether additional monitoring or follow-up care is needed. Healthcare providers should verify the serial numbers of implants they may have used.

The recalled product

Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07
Manufacturer
Exactech, Inc.
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 144-28-05
  • GUIDID 10885862027405
  • Serial Numbers: 646995
  • 646996
  • 646997
  • 646998
  • 667989
  • 667990
  • 667992
  • 667995
  • 667996
  • 668002
  • 668003
  • 668004
  • 770434
  • 770436
  • 770440
  • 770442
  • 770443
  • 770444

Distribution

Distributed nationwide across the United States.