GXL Hip Implant Liners Recalled for Packaging Defect Risk
Exactech is recalling specific GXL acetabular polyethylene hip implant liners because non-conforming packaging may cause accelerated wear. The company has distributed 4,956 affected devices worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—non-conforming packaging may cause accelerated wear of the implant liner—making this a voluntary precautionary recall rather than a direct risk-of-harm scenario.
Plain-English summary
Exactech, Inc. is recalling specific GXL acetabular polyethylene liners used as hip implant components. These devices were packaged in non-conforming bags that may adversely impact the liners and contribute to accelerated wear. Approximately 4,956 affected devices have been distributed worldwide, including to the United States and countries in Central America, South America, Europe, and Asia.
No injuries or illnesses have been reported. Patients with these hip implants should contact their surgeon or healthcare provider for guidance on appropriate follow-up.
The recalled product
- Product
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 2
- Manufacturer
- Exactech, Inc.
- Affected units
- 4,956
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 (20)
- a. REF 106-22-42
- GUDID 10885862014337
- Serial Numbers: 609855
- 609856
- 609857
- 609858
- 609859
- 609860
- 609862
- 609863
- 609864
- 609865
- 609867
- 609868
- 609869
- 609870
- 609871
- 609873
- 609874
- 609878
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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.
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Same hazard · accelerated wear
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FDA (Devices) · 2022-09-21
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