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

Products covered by this recall
Model / numberProduct as published
PE11151213USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm
PE1115121513x150mm
PE1115121715x150mm
PE1115141117x150mm
PE1115141311x200mm
PE1115141513x200mm
PE1115141715x200mm
Lot codes and dates
  • UDI(s)
    • 04719872153894
    • 04719872153924
    • 04719872153863
    • 04719872153870
    • 04719872149866
    • 04719872153900
    • 04719872153917
    • 04719872153887
  • Lot Number(s)

    118 of 118 codes

    • 15E198AA
    • 15E198AA12
    • 15E198AA22
    • 15E198AA23
    • 15E198S11
    • 15E198S12
    • 15E198W11
    • 15E198W111
    • 15E198X
    • 15E198X21
    • 15E198Y
    • 15E198Y11
    • 15E198Z
    • 15E198Z111
    • 15E198Z22
    • 15E198Z3
    • 16C168H
    • 16C168H21
    • 16C168H3
    • 16C168J
    • 16C168R1
    • 17H618E
    • 17H618E1
    • 17H618E2
    • 18A004A
    • 18A004B
    • 18A004B111
    • 18A004C2
    • 18A004C31
    • 18A004D
    • 18A004D1
    • 18A004D21
    • 18A004D22
    • 18A004E
    • 18A004E1
    • 18A004E112
    • 18A004F
    • 18A004F111
    • 18A004F211
    • 18A004F212
    • 18A004G
    • 18A004G1
    • 18A004G111
    • 18A004G2
    • 18A004G31
    • 18A004H
    • 18A004H212
    • 18A004W11
    • 20G378F2
    • 20H134A
    • 20H134A11
    • 20H134A3
    • 20H134B2
    • 21D124A
    • 21D124A1
    • 21D124A2
    • 21D124C1
    • 21D124C11
    • 21D512C
    • 21D512C1
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.

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.