USTAR II Knee System implants recalled for potential stem misalignment
The FDA is recalling USTAR II Knee System implants due to potential incorrect orientation of the curved stem. The defect may affect proper implant positioning in knee replacement surgery.
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 of a structural orthopedic implant with a potential defect in stem orientation. No illnesses or injuries have been reported, and the hazard is described as potential rather than confirmed. Per the rubric, recalls with risk-of-harm but no reported injuries are classified as High severity.
Plain-English summary
United Orthopedic Corporation is recalling USTAR II Knee System Cemented curved stem implants (right-hand side, non-coated) due to potential incorrect orientation of the curved stem. The recall involves 479 units across multiple part numbers and lot numbers.
The potential defect may affect the proper positioning and alignment of the implant during knee replacement surgery. An incorrectly oriented stem could impact surgical outcomes and long-term implant performance.
The recalled implants were distributed in the United States (California, Kentucky, Michigan, Indiana, Tennessee, Colorado, Florida, Texas, and Nevada) and internationally (Switzerland, United Kingdom, Malaysia, Philippines, and Taiwan). Specific lot numbers and UDI codes are listed by the FDA.
Patients who have received these implants should contact their surgeon or healthcare provider. Healthcare facilities should check their inventory against the provided lot numbers and UDI codes and follow the FDA's instructions for handling recalled units.
The recalled product
- Product
- USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x1
- Manufacturer
- United Orthopedic Corporation
- Hazard
- implant-misalignment
- device-defect
Distribution
Distributed in 9 states:
- CA
- CO
- FL
- IN
- KY
- MI
- NV
- TN
- TX
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