Hip Implant Liners Recalled Due to Risk of Premature Wear
Exactech Connexion GXL hip implant liners are being recalled due to a risk of edge-loading and premature prosthesis wear in patients with certain implant configurations and surgical positioning.
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 device recall documenting a risk of premature prosthesis wear and edge-loading. No patient injuries, hospitalizations, or illnesses have been reported. The hazard is theoretical rather than realized, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling Exactech Connexion GXL acetabular polyethylene liners used in hip replacement systems, including the Acumatch GXL 15 Degree Liner and Novation GXL Liners. The recall affects approximately 89,050 units distributed nationwide in the United States.
According to the FDA, these liners carry a risk of edge-loading and premature prosthesis wear in a specific subset of patients who have certain implant configurations combined with particular surgical positioning.
Patients who have received these implants should consult with their healthcare provider about their individual situation.
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped Ant, 36mm; and Novation GXL Liner, Lipped, 36mm. 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 (11)
- All serial numbers. UDI-DI numbers: 10885862023384
- 10885862023391
- 10885862023407
- 10885862023414
- 10885862023421
- 10885862023438
- 10885862023445
- 10885862303332
- 10885862303455
- 10885862303462
- 10885862303479
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 →- 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
- HighExactech Connexion GXL hip implant liners recalled for premature wear risk
FDA (Devices) · 2021-07-28
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