Exactech Hip Implant Liners Recalled Due to Premature Wear Risk
Exactech is recalling Connexion GXL hip implant liners due to edge-loading and premature wear risk in certain patient configurations. The recall affects 89,050 units 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 affecting hip implant liners with a documented risk of edge-loading and premature wear. No illnesses or injuries are reported, making this a risk-of-harm product where injury has not yet been documented.
Plain-English summary
Exactech, Inc. is recalling Connexion GXL acetabular polyethylene liners used in hip replacement systems (catalog numbers 138-32-XX, 138-36-XX, and 138-40-XX). The recall affects 89,050 units distributed nationwide.
The recalled liners carry a risk of edge-loading and premature prosthesis wear in patients with certain implant configurations and specific surgical implant positioning. This risk applies only to a specific subset of patients.
Patients who have received these implants should contact their healthcare provider to discuss their individual risk and determine what follow-up care may be appropriate. Healthcare providers can identify affected devices using the specific UDI-DI numbers and catalog numbers provided by the FDA.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL
- Manufacturer
- Exactech, Inc.
- Hazard
- edge-loading
- premature-prosthesis-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 (14)
- All serial numbers. UDI-DI numbers: 138-32-XX: 10885862024732
- 10885862024749
- 10885862024756
- 10885862024763
- 10885862024770. 138-36-XX: 10885862024817
- 10885862024824
- 10885862024831
- 10885862024848
- 10885862024886
- 10885862024893
- 10885862024909
- 10885862024916. 138-40-XX: 10885862208804
- 10885862208811
- 10885862208828.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03