The Recall Desk
HighFDA (Devices)·Z-2125-2021·Announced 2021-07-28

Exactech Connexion GXL hip implant liners recalled for premature wear risk

Exactech is recalling 89,050 hip implant liners due to edge-loading and premature wear risk in a subset of patients with certain implant configurations.

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 medical device with a structural defect risk (edge-loading and premature wear) affecting orthopedic hip implants. No illnesses or injuries have been reported, placing this at severity level 3 as a risk-of-harm product without reported adverse events.

Plain-English summary

Exactech, Inc. is recalling Connexion GXL acetabular polyethylene liners, components of orthopedic hip implant systems. The recall encompasses approximately 89,050 units distributed nationwide in the United States, including all serial numbers of the specified product (Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID).

The recalled liners present a risk of edge-loading and premature prosthesis wear in a specific subset of patients when certain implant configurations are combined with specific surgical implant positioning. This accelerated wear could compromise the long-term performance of the hip implant.

This is an FDA Class II recall. Patients with these implants should contact their healthcare provider or the manufacturer for additional information and guidance regarding their individual implant and clinical situation.

The recalled product

Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID. Orthopedic hip implant component.
Manufacturer
Exactech, Inc.
Category
Medical Device — Hip Implant / Acetabular Liner
Hazard
  • edge-loading
  • premature-wear

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: 10885862024190

Distribution

Distributed nationwide across the United States.

Related recalls

Same category