Exactech Connexion GXL Hip Implant Liners Recall Risk of Premature Wear
Exactech is recalling 89,050 Connexion GXL acetabular hip implant liners due to risk of edge-loading and premature wear in certain patient configurations and surgical placements.
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 recall of an orthopedic implant with potential for premature wear and edge-loading. No injuries or hospitalizations have been reported in the source material. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Exactech, Inc. is recalling all serial numbers of Connexion GXL acetabular polyethylene liners used in Novation GXL systems with catalog numbers 136-32-XX, specifically the +5mm Lateralized, 32mm model. A total of 89,050 units have been distributed nationwide in the United States.
The liners are being recalled due to a risk of edge-loading and premature prosthesis wear in certain patient configurations and surgical implant positioning. This potential issue could affect the longevity and function of the implant.
Patients with these implant components should consult with their orthopedic surgeon to determine if they have been affected and to discuss appropriate management. Physicians and patients can identify affected devices using the provided UDI-DI numbers (10885862024275, 10885862024282, 10885862024299, 10885862024305, 10885862024312).
The recalled product
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. 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 (5)
- All serial numbers. UDI-DI numbers: 10885862024275
- 10885862024282
- 10885862024299
- 10885862024305
- 10885862024312
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
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