The Recall Desk
HighFDA (Devices)·Z-2130-2021·Announced 2021-07-28

Exactech Connexion GXL hip implant liners risk edge-loading and wear

Exactech Connexion GXL acetabular polyethylene liners used in hip replacements may experience edge-loading and premature wear in certain patients due to implant configuration or surgical positioning. Approximately 89,050 units were distributed nationwide.

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: FDA Class II recall of an orthopedic implant component with documented risk of mechanical failure (edge-loading and premature wear). No illnesses or injuries have been reported, making this a risk-of-harm medical device without reported harm, which per the rubric qualifies for level 3.

Plain-English summary

Exactech, Inc. is recalling Connexion GXL acetabular polyethylene liners, components used in orthopedic hip replacement systems. The recalled product includes catalog numbers 138-22-XX and all associated serial numbers, with approximately 89,050 units distributed nationwide.

The liners pose a risk of edge-loading and premature wear in patients with certain implant configurations or surgical positioning. This risk could result in accelerated prosthesis wear and potential implant failure over time.

Patients who received these hip replacements should contact their surgeon or healthcare provider. Healthcare providers should review patient records to identify individuals with the affected liner models and determine whether monitoring, replacement, or additional intervention is necessary.

The recalled product

Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.
Manufacturer
Exactech, Inc.
Category
Medical Device — Orthopedic / Hip Implant
Hazard
  • edge-loading
  • premature-wear
  • implant-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 (1)

  • All serial numbers. UDI-DI number: 10885862024503

Distribution

Distributed nationwide across the United States.

Related recalls

Same category