Exactech Connexion GXL Hip Implant Liners Recalled for Premature Wear Risk
Exactech is recalling 89,050 Connexion GXL acetabular hip implant liners due to a risk of edge-loading and premature wear in certain implant configurations. No illnesses or injuries have been reported.
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: Class II medical device with potential for serious harm (hip implant failure) affecting a specific patient subset, but no injuries or illnesses reported. Risk-of-harm product where injury has not yet been reported, per severity rubric criterion for Score 3.
Plain-English summary
Exactech, Inc. is recalling 89,050 Connexion GXL acetabular polyethylene liners used in hip replacement systems distributed nationwide in the United States. The recalled liners include Catalog numbers 130-32-XX (Acumatch GXL 0 Degree Liner, 32mm) and Novation GXL Liner (Neutral, 32mm).
The FDA determined that these liners pose a risk of edge-loading and premature wear in a specific subset of patients with certain implant configurations and surgical implant positioning. While no injuries or illnesses have been reported to date, premature wear of hip implant components can lead to implant loosening and the need for revision surgery.
Patients who have received one of these implants should contact their healthcare provider to discuss their individual risk. Healthcare providers should consult Exactech and the FDA recall notice for complete guidance and instructions.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral, 32mm. Orthopedic hip implant component.
- Manufacturer
- Exactech, Inc.
- Hazard
- premature-wear
- edge-loading
- 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 (9)
- All serial numbers. UDI-DI numbers: 10885862022097
- 10885862022103
- 10885862022110
- 10885862022127
- 10885862207074
- 10885862022165
- 10885862022172
- 10885862022189
- 10885862022196
Distribution
Distributed nationwide across the United States.
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