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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

United Orthopedic Corporation: USTAR II Hip and Knee Systems Recalled for Potential Incorrect Stem Orientation

Agency Publication Date: February 29, 2024
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Summary

United Orthopedic Corporation is recalling approximately 1,077 units of its USTAR II Hip and Knee System curved stems because there is a potential for the implant stems to be oriented incorrectly. This recall affects various models of the Press-Fit and Cemented curved stems manufactured in Taiwan. These components are used in orthopedic surgeries, and any patient with one of these implants may be affected by this orientation issue.

Risk

If the implant stem is oriented incorrectly during manufacturing or assembly, it may not align properly within the patient's bone during surgery. This can lead to surgical complications, improper joint function, or the need for revision surgery to correct the alignment. No specific injuries have been reported in the provided data.

What You Should Do

  1. Check your medical records or contact your orthopedic surgeon to determine if a USTAR II Hip or Knee System curved stem was used in your procedure.
  2. Verify if your implant matches the affected reference numbers, such as Hip System PE11151211 through PE11151417, or Knee System PE25153109 through PE25151415.
  3. Identify your specific lot number and UDI from your device identification card; affected lots include codes like 15E198AA, 23B622AW, and 21D124A (refer to the full list of over 100 affected lot codes).
  4. If you have an affected implant, schedule a consultation with your healthcare provider to discuss the status of your implant and any necessary monitoring.
  5. Contact United Orthopedic Corporation directly at their Hsinchu, Taiwan headquarters or through your local distributor for technical details and guidance regarding this voluntary recall.
  6. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray
Model / REF:
PE11151211 (11x150mm)
PE11151213 (13x150mm)
PE11151215 (15x150mm)
PE11151217 (17x150mm)
PE11151411 (11x200mm)
PE11151413 (13x200mm)
PE11151415 (15x200mm)
PE11151417 (17x200mm)
UPC Codes:
04719872153894
04719872153924
04719872153863
04719872153870
04719872149866
04719872153900
04719872153917
04719872153887
Lot Numbers (118):
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
Product: USTAR II Knee System Cemented curved stem, RHS, Non Coated
Model / REF:
PE25153109 (9x125mm)
PE25153209 (9x150mm)
PE25153113 (13x125mm)
PE25153111 (11x125mm)
PE25153115 (15x125mm)
PE25153211 (11x150mm)
PE25153213 (13x150mm)
PE25153217 (17x150mm)
PE25153117 (17x125mm)
PE25153015 (15x100mm)
PE25153215 (15x150mm)
UPC Codes:
04711605584562
04711605584579
04711605584586
04711605584616
04711605584630
04719872149866
04719872153542
04719872153559
04719872153566
04719872153573
04719872153610
04719872153658
04719872153665
04719872153672
04719872153689
04719872153696
04719872153863
04719872153870
04719872153887
04719872153894
04719872153900
04719872153917
04719872153924
04719872154341
04719872154358
04719872154365
04719872154372
04719872154389
04719872154396
04719872154402
04719872154419
Lot Numbers (128):
15E198AA
15E198S11
15E198Y
15E198Z
15E198Z111
16C168H
16C168H3
16C168J
16F306B2
16F306C
16F306C1
16F306E121
16H278K1
16H278K111
16H278K3
16H278L1
16H278L31
16H278N2
16H280D1
16H280D31
16H280D4
16H280E1
16H280E11
16H280E3
16H280F11
17B448AY13
17H618E1
18A004B
18A004C2
18A004D
18A004D1
18A004F
18A004G
18A004G1
18A004W11
18C255FG
18C255FG11
18C255FG12
18C255K31
18C255R
18C255W11
18C255X
18C255X1
18C255Y131
18C256A122
19G738DN
19G738DN12
19G738DN3
19G738DP
19G738DQ
Product: USTAR II Knee System Cemented Curved Stem, RHS Ti Plasma Spray
Model / REF:
PE25153109 (9x125mm)
PE25151109 (9x125mm)
PE25151111 (11x125mm)
PE25151113 (13x125mm)
PE25151115 (15x125mm)
PE25151117 (17x125mm)
PE25151119 (19x125mm)
PE25151209 (9x150mm)
PE25151211 (11x150mm)
PE25151213 (13x150mm)
PE25151215 (15x150mm)
PE25151217 (17x150mm)
PE25151415 (15x200mm)
UPC Codes:
04711605584562
04711605584579
04711605584586
04711605584616
04711605584630
04719872149866
04719872153542
04719872153559
04719872153566
04719872153573
04719872153610
04719872153658
04719872153665
04719872153672
04719872153689
04719872153696
04719872153863
04719872153870
04719872153887
04719872153894
04719872153900
04719872153917
04719872153924
04719872154341
04719872154358
04719872154365
04719872154372
04719872154389
04719872154396
04719872154402
04719872154419
Lot Numbers (128):
15E198AA
15E198S11
15E198Y
15E198Z
15E198Z111
16C168H
16C168H3
16C168J
16F306B2
16F306C
16F306C1
16F306E121
16H278K1
16H278K111
16H278K3
16H278L1
16H278L31
16H278N2
16H280D1
16H280D31
16H280D4
16H280E1
16H280E11
16H280E3
16H280F11
17B448AY13
17H618E1
18A004B
18A004C2
18A004D
18A004D1
18A004F
18A004G
18A004G1
18A004W11
18C255FG
18C255FG11
18C255FG12
18C255K31
18C255R
18C255W11
18C255X
18C255X1
18C255Y131
18C256A122
19G738DN
19G738DN12
19G738DN3
19G738DP
19G738DQ

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93858
Status: Active
Manufacturer: United Orthopedic Corporation
Sold By: Orthopedic surgeons; Hospitals; Surgical centers
Manufactured In: Taiwan
Units Affected: 2 products (598 units; 479 units)
Distributed To: California, Kentucky, Michigan, Indiana, Tennessee, Colorado, Florida, Texas, Nevada

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.