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
26 of 26 products
| Model / number | Product as published |
|---|---|
130-28-51 | NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS |
130-32-52 | NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS |
130-36-53 | NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS |
130-36-54 | NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 4 CUPS |
130-36-55 | NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 5 CUPS |
136-32-53 | NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 3 CUPS |
136-32-54 | NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 4 CUPS |
136-32-55 | NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 5 CUPS |
136-28-51 | NOVATION GXL LINER, +5LAT, 28MM G1-48/50MM CUPS |
136-32-51 | NOVATION GXL LINER, +5LAT, 32MM G1-48/50MM CUPS |
136-32-52 | NOVATION GXL LINER, +5LAT, 32MM G2-52/54MM CUPS |
136-36-52 | NOVATION GXL LINER, +5LAT, 36MM G2-52/54MM CUPS |
136-36-53 | NOVATION GXL LINER, +5LAT, 36MM G3-56/58MM CUPS |
136-36-54 | NOVATION GXL LINER, +5LAT, 36MM G4-60/62MM CUPS |
136-36-55 | NOVATION GXL LINER, +5LAT, 36MM G5-64/66/68MM CUPS |
138-32-51 | NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 1 CUP |
138-32-53 | NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 3 CUP |
138-36-52 | NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 2 CUP |
138-36-53 | NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 3 CUP |
138-36-54 | NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 4 CUP |
- Lot codes and dates
a. REF 130-28-51GUDID 10885862022066
- Serial Numbers
1,362 of 1,362 codes
101880010188011018805101880610188081018809101881010188141018815101881610188171018818101882310188241018832101883410188351018836101884510188481018850114985411498551149861114986311498651149866114986711498681149869114987111498771149878114987911498801149881114988211498831217194121719512171961217197121719912172011217202121720412172051217206121720712172081217209121721012172111217212121721512172161217217121721812172191217220
- Serial Numbers
2,250 of 2,250 codes
102481410248151024816102481710248181024820102482110248221024823102482410248251024826102482710248281024829102483010248311024832102483310248341024835102483610248371024838102483910248401024841102484210248441024845102484610248471024848102485010248511024852102485310248541024855102485610248571024858102485910248601024861102486210248631024864102486510248661024867102486810248691024870102487110248721024873102487410248751024876
- Amount recalled
- 58158 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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