Exactech Connexion GXL Hip Implant Liners Recalled for Premature Wear Risk
Exactech Connexion GXL hip implant liners are being recalled due to risk of edge-loading and premature wear in certain surgical configurations. Approximately 89,050 units distributed nationwide may be affected.
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 FDA Class II medical device recall involves orthopedic hip implant liners with potential for premature wear and device failure. As a risk-of-harm medical device without documented illnesses or hospitalizations, it meets the criteria for High severity but falls below Severe classification.
Plain-English summary
Exactech, Inc. is recalling Connexion GXL acetabular polyethylene liners, orthopedic hip implant components used in hip replacement surgery. The recalled devices include catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG, and MCS GXL Liner 5/15 DEG, representing approximately 89,050 units distributed nationwide.
The liners present a risk of edge-loading and premature prosthesis wear in a specific subset of patients with certain implant configurations and surgical implant positioning. This can potentially lead to premature component failure and may require revision surgery.
Healthcare providers should review the implant serial numbers and UDI-DI numbers provided by the FDA to identify affected devices. Patients who received these implants should consult with their healthcare provider regarding their specific device.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. 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 (9)
- All serial numbers. UDI-DI numbers: 10885862013491
- 10885862013507
- 10885862013514
- 10885862013521
- 10885862013538
- 10885862013545
- 10885862013569
- 10885862013576
- 10885862013583
Distribution
Distributed nationwide across the United States.
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