Hip Implant System Recalled for Potential Incorrect Stem Orientation
United Orthopedic Corporation is recalling the USTAR II Hip System Press-Fit Curved Stem due to a potential risk that the implant curved stem may be oriented incorrectly. The FDA Class II recall affects 598 units.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The potential for incorrect stem orientation of a surgical hip implant constitutes a risk-of-harm product where injury has not yet been reported, qualifying it as High (3) severity per the rubric.
Plain-English summary
The USTAR II Hip System Press-Fit Curved Stem (RHS Ti Plasma Spray), manufactured by United Orthopedic Corporation, is subject to an FDA Class II recall. The concern is a potential risk that the implant curved stem may be oriented incorrectly.
The recall involves 598 units distributed to medical facilities in the United States (California, Kentucky, Michigan, Indiana, Tennessee, Colorado, Florida, Texas, and Nevada) as well as internationally (Switzerland, United Kingdom, Malaysia, Philippines, and Taiwan). Multiple production lot numbers spanning 2015 through 2023 are affected.
No illnesses or injuries related to the potential incorrect orientation have been reported. Patients who have received this implant and their healthcare providers should be aware of this recall and may seek further information from United Orthopedic Corporation or the FDA regarding any necessary follow-up.
The recalled product
- Product
- USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417
- Manufacturer
- United Orthopedic Corporation
- Hazard
- implant-misorientation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI(s): 04719872153894
- 04719872153924
- 04719872153863
- 04719872153870
- 04719872149866
- 04719872153900
- 04719872153917
Distribution
Distributed in 9 states:
- CA
- CO
- FL
- IN
- KY
- MI
- NV
- TN
- TX
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