The Recall Desk
HighFDA (Devices)·Z-1732-2022·Announced 2022-09-21

Exactech GXL Acetabular Hip Implant Liners Recalled for Accelerated Wear

Exactech GXL acetabular hip implant liners may have been packaged in non-conforming bags, which could contribute to accelerated device wear. Approximately 17,929 units were 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 Class II recall of orthopedic hip implant components due to packaging defects that may contribute to accelerated device wear. While no injuries or illnesses have been reported, premature implant failure represents a risk-of-harm situation potentially requiring revision surgery.

Plain-English summary

Exactech, Inc. is recalling specific GXL acetabular polyethylene liners, orthopedic components used in hip replacement surgery. Approximately 17,929 units have been affected by this recall.

The liners were packaged in non-conforming bags. FDA determined that non-conforming packaging may adversely impact the device and contribute to accelerated wear of the acetabular liner over time. The affected devices were distributed worldwide, including throughout the United States and to countries in South America, Asia, Europe, and the Caribbean.

The recall involves multiple product variants with specific reference numbers and serial number ranges. Healthcare providers and patients should refer to the FDA recall notice for complete identification information to determine if an individual device is affected.

The recalled product

Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 1
Manufacturer
Exactech, Inc.
Category
Medical Device — Orthopedic / Hip Implant
Hazard
Affected units
17,929

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 130-32-51
  • GUDID 10885862207074
  • Serial Numbers: 2409984
  • 2409985
  • 2409986
  • 2409987
  • 2409988
  • 2409989
  • 2409990
  • 2409991
  • 2409993
  • 2409994
  • 2409995
  • 2409996
  • 2409997
  • 2409998
  • 2409999
  • 2410000
  • 2410001
  • 2410002

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Related recalls

Same manufacturer · Exactech, Inc.

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Same hazard · accelerated wear

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