Reported Sep 21, 2022 · Ongoing
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers
5 of 5 products
| Model / number | Product as published |
|---|---|
138-36-08 | ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H |
138-36-09 | ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J |
132-36-08 | ACUMATCH LINER 15 DEG 36MM ID, SIZE H |
132-36-09 | ACUMATCH LINER 15 DEG 36MM ID, SIZE J |
132-36-10 | ACUMATCH LINER 15 DEG 36MM ID, SIZE K |
- Amount recalled
- 132 devices
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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