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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 89,050
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.
Part of a larger recall action
This product is one of 22 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
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Same hazard · edge loading
See all →- HighExactech Hip Implant Liners Recalled Due to Premature Wear Risk
FDA (Devices) · 2021-07-28
- HighHip implant liners recalled for edge-loading and premature wear
FDA (Devices) · 2021-07-28
- HighExactech Connexion GXL Hip Implant Liners Recall Risk of Premature Wear
FDA (Devices) · 2021-07-28
- HighExactech GXL Hip Implant Liners Recalled for Premature Wear Risk
FDA (Devices) · 2021-07-28
- HighHip implant acetabular liners recalled for edge-loading and premature wear
FDA (Devices) · 2021-07-28
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