Reported Mar 6, 2024 · Ongoing
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 -…
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?
7 of 7 products
| Model / number | Product as published |
|---|---|
PE11151213 | USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm |
PE11151215 | 13x150mm |
PE11151217 | 15x150mm |
PE11151411 | 17x150mm |
PE11151413 | 11x200mm |
PE11151415 | 13x200mm |
PE11151417 | 15x200mm |
- Lot codes and dates
- UDI(s)
0471987215389404719872153924047198721538630471987215387004719872149866047198721539000471987215391704719872153887
- Lot Number(s)
118 of 118 codes
15E198AA15E198AA1215E198AA2215E198AA2315E198S1115E198S1215E198W1115E198W11115E198X15E198X2115E198Y15E198Y1115E198Z15E198Z11115E198Z2215E198Z316C168H16C168H2116C168H316C168J16C168R117H618E17H618E117H618E218A004A18A004B18A004B11118A004C218A004C3118A004D18A004D118A004D2118A004D2218A004E18A004E118A004E11218A004F18A004F11118A004F21118A004F21218A004G18A004G118A004G11118A004G218A004G3118A004H18A004H21218A004W1120G378F220H134A20H134A1120H134A320H134B221D124A21D124A121D124A221D124C121D124C1121D512C21D512C1
- UDI(s)
- Amount recalled
- 598 units
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.
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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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