Hip implant liners recalled for edge-loading and premature wear
Exactech Connexion GXL hip implant liners are recalled due to risk of edge-loading and premature wear in certain configurations. About 89,050 units distributed nationwide are 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 is an FDA Class II medical device recall based on a potential risk of edge-loading and premature wear in hip implant components. The hazard is theoretical rather than based on reported injuries, meeting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling Connexion GXL acetabular polyethylene liners, components of orthopedic hip implant systems. The affected product includes 28mm liners with catalog number 134-28-XX used in Acumatch GXL Ext Cov systems. Approximately 89,050 units have been distributed nationwide, with all serial numbers potentially affected.
The recall addresses a risk of edge-loading and premature prosthesis wear in a specific subset of patients. This risk is associated with certain implant configurations and surgical positioning at the time of implantation.
The potential for prosthesis wear could affect implant durability. Patients and their healthcare providers can identify affected implants using the UDI-DI numbers and serial numbers provided.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Liner, 28mm. Orthopedic hip implant component.
- Manufacturer
- Exactech, Inc.
- Category
- Medical Device — Hip implant
- 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 (6)
- All serial numbers. UDI-DI numbers: 10885862023919
- 10885862023926
- 10885862023933
- 10885862023940
- 10885862023957
- 10885862023964
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
- 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
- HighExactech Connexion GXL hip implant liners recalled for premature wear risk
FDA (Devices) · 2021-07-28
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