Hip implant polyethylene liners recalled due to premature wear risk
Exactech Connexion GXL acetabular liners used in hip implants are recalled due to risk of edge-loading and premature wear in patients with specific implant configurations and surgical positioning.
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 affecting orthopedic hip implants with a risk of premature wear and edge-loading. No illnesses or injuries are reported in the source text, and the risk is limited to a specific subset of patients with certain implant configurations. This fits the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling approximately 89,050 Connexion GXL acetabular polyethylene liners used as components in hip implant systems, including Acumatch GXL 0 Degree and Novation GXL Neutral models. These are distributed nationwide in the United States.
The liners are being recalled because edge-loading and premature prosthesis wear is possible in a specific subset of patients when certain implant configurations are combined with particular surgical implant positioning.
Patients who have received these implants should consult with their healthcare provider or surgeon if they have any concerns, particularly if their implant matches the configurations described in this recall.
For questions or additional information about this recall, contact Exactech, Inc. or the FDA.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hip implant component.
- Manufacturer
- Exactech, Inc.
- 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 (7)
- All serial numbers. UDI-DI numbers: 10885862022202
- 10885862022219
- 10885862022226
- 10885862207081
- 10885862022233
- 10885862022240
- 10885862022257
Distribution
Distributed nationwide across the United States.
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