Exactech Hip Implant Liners Recalled Due to Premature Wear Risk
Exactech is recalling certain acetabular polyethylene hip implant liners due to risk of edge-loading and premature wear in specific implant configurations and surgical positions.
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 an FDA Class II medical device recall involving risk of harm to patients with specific implant configurations. No illnesses or injuries have been reported in the source material. Per the rubric, risk-of-harm products where injury has not yet been reported receive a 'High' (3) rating.
Plain-English summary
Exactech, Inc. is recalling certain Connexion GXL acetabular polyethylene liners used in hip implant systems, including Acumatch GXL and Novation GXL models in 28mm size. Approximately 89,050 units were distributed nationwide.
The liners pose a risk of edge-loading and premature prosthesis wear in a specific subset of patients with certain implant configurations and particular surgical implant positioning. Premature wear can lead to implant degradation and may necessitate revision surgery.
Patients who have received these implants should contact their orthopedic surgeon or healthcare provider to discuss their individual implant configuration and surgical positioning. Healthcare providers and patients can also contact Exactech, Inc. for additional information about the recalled liners and steps to monitor their implant.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.
- Manufacturer
- Exactech, Inc.
- Hazard
- implant-wear
- edge-loading
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 (8)
- All serial numbers. UDI-DI numbers: 10885862024589
- 10885862024596
- 10885862024602
- 10885862024619
- 10885862024626
- 10885862024633
- 10885862024664
- 10885862024671
Distribution
Distributed nationwide across the United States.
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