Reported Mar 6, 2024 · Ongoing
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 -…
United Orthopedic Corporation
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: United Orthopedic Corporation · No. 57 Park Avenue 2, Science Park · Hsinchu · N/A
Is this the product you have?
- USTAR II Knee SystemCemented Curved Stem, RHS Ti Plasma Spray
- Reference Numbers
REF: PE25153109 - PE25151109 - 9x125mmPE25151111 - 11X125PE25151113 - 13X125mmPE25151115 - 15X125mmPE25151117 - 17X125mmPE25151119 - 19X125mmPE25151209 - 9X150mmPE25151211 - 11X150PE25151213 - 13X150mmPE25151215 - 15X150mmPE25151217 - 17X150mmPE25151415 - 15x200mm
- Lot codes and dates
- UDI(s)
04711605584562047116055845790471160558458604711605584616047116055846300471987214986604719872153542047198721535590471987215356604719872153573047198721536100471987215365804719872153665047198721536720471987215368904719872153696047198721538630471987215387004719872153887047198721538940471987215390004719872153917047198721539240471987215434104719872154358047198721543650471987215437204719872154389047198721543960471987215440204719872154419
- Lot Number(s)
128 of 128 codes
15E198AA15E198S1115E198Y15E198Z15E198Z11116C168H16C168H316C168J16F306B216F306C16F306C116F306E12116H278K116H278K11116H278K316H278L116H278L3116H278N216H280D116H280D3116H280D416H280E116H280E1116H280E316H280F1117B448AY1317H618E118A004B18A004C218A004D18A004D118A004F18A004G18A004G118A004W1118C255FG18C255FG1118C255FG1218C255K3118C255R18C255W1118C255X18C255X118C255Y13118C256A12219G738DN19G738DN1219G738DN319G738DP19G738DQ19G738DR1219G738DW1219K248AR19K248AS19L428CZ219L428W219L496C19L496C119L496C11119L496D
- UDI(s)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Their is a potential that the implant curved stem may be oriented incorrectly.
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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