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
19 of 19 products
| Model / number | Product as published |
|---|---|
106-22-42 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42 |
106-22-44 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44 |
106-22-46 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46 |
106-22-48 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48 |
106-22-50 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50 |
106-22-52 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52 |
106-22-54 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54 |
106-28-48 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48 |
106-28-50 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50 |
106-28-52 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52 |
106-28-54 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54 |
106-28-56 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56 |
106-28-58 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58 |
106-28-60 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60 |
106-32-52 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52 |
106-32-54 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54 |
106-32-56 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56 |
106-32-58 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58 |
106-32-60 | ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60 |
- Lot codes and dates
a. REF 106-22-42GUDID 10885862014337
- Serial Numbers
187 of 187 codes
6098556098566098576098586098596098606098626098636098646098656098676098686098696098706098716098736098746098786098796098809143539143549143559143569143579143589143599143609143619143629143639143649967219967229967239967249967259967269967279967289967309967319967329967339967349967359967369967379967389967391049244104924510492461049247106875810687591068760106876110687621068763
- Serial Numbers
259 of 259 codes
639981639983639984639985639987639988639991639992639993639996639997640000640001640003640004640005640006817951817952817953817954817955817956817957817958817959817960817961817962817963817964817965817966817967817968817969817970817971817972817973817974817975817976817977817978817979918337918338918339918340918341918342947926947927947928948966948967948968948969948970
- Serial Numbers
379 of 379 codes
607057607058607062607065607066607067607069607073607074607079639619639621639622639623639624639625639626639627639628639629639630639631639632639633639635639636639637639638639640639641639642639643814278814279814280814281814282814283814284814285814286814287814288814289814290814291814292814293814294814295814296814297814298822453822454822455822457822458822459822460
- Serial Numbers
9474219474229474249474259474269474289474299474379474429474451688077168807816880791688081168808316880842168203e. REF 106-22-50GUDID 10885862014375
- Serial Numbers
9054929054979054999055009055039055059055142062753206275720627672062773f. REF 106-22-52GUDID 10885862014382
- Serial Numbers
94916694917194917394917494917619703471970348967454967459h. REF 106-28-48GUDID 10885862014603
- Serial Numbers
1,922 of 1,922 codes
595247595248595249595250595251595252595253595254595255595256595258595259595260595261595262595263595264595265595266595267595268595269595270595271595272614753614754614755614756614757614758614759614760614761614762614763614764614765614766614767614768614769614770614771614772614773614774614775614776614777614778640037640038640039640040640041640043640044640045640046
- Serial Numbers
909 of 909 codes
598300598301598302598303598304598305598307598310598311598312598313598314598315598316598318598319598321598323598324622440622441622442622443622444622445622446622447622448622450622451622452622453622454622455622456622457622458622459622460643323643324643325643326643328643329643330643331643332643333643334643335643336643338643339643340643341643343643344643345643346
- Amount recalled
- 4956 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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