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
4 of 4 products
| # | Product as published |
|---|---|
| 1 | GXL NEUTRAL LINER, G0 28MM ID, 130-28-50 |
| 2 | GXL NEUTRAL LINER, G00 22MM ID, 130-22-70 |
| 3 | NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50 |
| 4 | NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70 |
- Lot codes and dates
a. 130-28-50GUDID 10885862022059
- Serial Numbers
406 of 406 codes
178499517849961784998178500017850021785003178500617850111785012178501317850151785016178501717850181785022178502417850261785027178503017850321785033179663717966401796641179664217966441796647179665217966541796655179665617966581810811181081318108141810818181081918108211810822181082518108281810829181083118108321859562254014425401452540146254014725401482540150263343226334332691744269174626917472691748269174926917502691751
- Serial Numbers
1787743178775717877581787764282759428275952827596282759728275982827599282760028276012827602282760328276042827605282760628276072827608282760928276102900032c. 132-28-50GUDID 10885862023148
- Serial Numbers
3,179 of 3,179 codes
178508217850831785084178508817850891785091178509217850961785097178509817850991785100178510117851061785108178511017851151785117178511917851201785121178512217851231797031179703217970331797034179703517970391797041179704217970431797046179704717970501811551181155218115531811554181155618115571811559181156018115611811563181156418115651811566181156718115681811569185250618525071852508185250918525121852513185251518525161852517
- Amount recalled
- 3793 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.
Want the full recall guide?
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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