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
16 of 16 products
| Model / number | Product as published |
|---|---|
130-32-51 | NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS |
130-36-52 | NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS |
130-40-53 | NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS |
130-40-54 | NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS |
130-40-55 | NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS |
132-32-51 | NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS |
132-36-52 | NOVATION GXL LINER LIPPED 36MM ID GROUP 2 |
132-40-53 | NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS |
132-40-54 | NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS |
132-40-55 | NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS |
136-40-53 | NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS |
136-40-54 | NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS |
136-40-55 | NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS |
138-40-53 | NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP |
138-40-54 | NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP |
138-40-55 | NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP |
- Lot codes and dates
a. REF 130-32-51GUDID 10885862207074
- Serial Numbers
3,616 of 3,616 codes
240998424099852409986240998724099882409989240999024099912409993240999424099952409996240999724099982409999241000024100012410002241000324100042410005241000624100072410008241000924100102410011241001224100132410014242408124240822424083242408424240852424086242408724240882424089242409024240912424092242409324240942424096242409724240982424099242410024331912433192243319324331942433195243319624331972433198243319924332002433201
- Amount recalled
- 17929 units
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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