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 |
|---|---|
134-28-41 | NOVATION CONSTRAINED LINER 28MM ID GROUP 1 |
134-32-42 | NOVATION CONSTRAINED LINER 32MM ID GROUP 2 |
134-36-43 | NOVATION CONSTRAINED LINER 36MM ID GROUP 3 |
134-36-44 | NOVATION CONSTRAINED LINER 36MM ID GROUP 4 |
134-36-45 | NOVATION CONSTRAINED LINER 36MM ID GROUP 5 |
- Lot codes and dates
a. REF 134-28-41GUDID 10885862023971
- Serial Numbers
732 of 732 codes
115270611527071152709115271111527121152713115271411527161152717115271911527211152722115272411527251338587133858813385891338590133859213385931338594133859513385981338599133860013386011338602133860313386041504513150451615149691514972152117115211721521173152117415211751521176152117715211781521179152118015211811665721166572216657231665724166572516657281665730166573216657331665734166573516657371665738182175718217581821759
- Serial Numbers
840 of 840 codes
115293311529351152936115293711529381152939115294011529411152942115294311529441152945115294611529471152948115294911529501332353133235413323551332356133235713323581332359133236013323611332362133236313323641332366133236713323681332370133237113323721363147136314813631501363151136315413631561363157136315813631591363160136316213631631363165136316614995701499571149957214995751517160151716215171631517164151716515171661589904
- Serial Numbers
479 of 479 codes
115291311529141152915115291611529171152918115291911529211152922115292311529261152927115292811529291152931115293213344131334414133441513344161334417133441813344201334421133442313344241334425133442713344301334432139629913963011396302139630313963041396305139630713963091396310139631213963131396314139631713963181396319152191015219121521913152191415219161521917152191815219191521920152192115219221605519160552016055211605522
- Serial Numbers
220 of 220 codes
115272711527281152729115273011527311152732115273511527361152737115273911527401152742115274511527461338518133851913385201338522133852313385241338525133852613385271338530133853113385321338533133853413385351338536133853713385381516138152074415207451520749152075015207511520754179373017937311793732179373417937351793736182215818221591822160182216118221621822163182216618440811844083184408518440861844087184408818440891924327
- Serial Numbers
11527711152772115277311527781152779115278011527821152784133860713386081338616133861713386211338624133862615221591522160152216216418551641858164186016418641641865164186716418681641869200619520061962006197201090920109112010913201091520109202010921248129326777432778776280031329762442976245297624629762472976248297624929762512976252297625337682163768219376822537682294137300413731441373164622463
- Amount recalled
- 2319 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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