The Recall Desk
HighFDA (Devices)·Z-2115-2021·Announced 2021-07-28

Exactech Hip Implant Liners Recalled Due to Premature Wear Risk

Exactech is recalling 89,050 Connexion GXL acetabular polyethylene hip implant liners due to risk of premature prosthesis wear in certain patient configurations and surgical positioning scenarios.

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 medical device recall with no reported illnesses or injuries in the source text. The hazard—edge-loading and premature prosthesis wear—is a theoretical risk affecting a specific subset of patients. Per the rubric, recalls with theoretical hazards and no reported injuries score at most 3 (High).

Plain-English summary

Exactech, Inc. is recalling 89,050 Connexion GXL acetabular polyethylene liners used as orthopedic hip implant components. These liners are distributed nationwide throughout the United States.

The recall was initiated due to a risk of edge-loading and premature prosthesis wear that may occur in a specific subset of patients. This risk is present in patients with certain implant configurations combined with specific surgical implant positioning techniques.

Patients who have received this hip implant component should contact their healthcare provider or surgeon if they have concerns about their implant. Healthcare providers should refer to FDA and manufacturer communications for guidance on patient management and potential follow-up options.

The recalled product

Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant component.
Manufacturer
Exactech, Inc.
Hazard
  • premature-wear
  • implant-failure

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: 10885862021892

Distribution

Distributed nationwide across the United States.