Orthopedic knee implant recall due to potential stem misalignment
United Orthopedic Corporation recalls USTAR II knee implants due to potential incorrect orientation of the curved stem. Affected products were distributed across multiple US states and internationally.
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 medical device recall for an orthopedic implant with a potential structural defect (stem orientation). No illnesses, injuries, or hospitalization cases have been reported; the hazard is theoretical rather than confirmed, limiting the score to High per the rubric.
Plain-English summary
United Orthopedic Corporation is recalling USTAR II Knee System components, specifically the cemented curved stem with titanium plasma spray coating, across multiple reference numbers and lot numbers.
The recall addresses a potential that the implant curved stem may be oriented incorrectly.
Affected 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).
The recalled product
- Product
- USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11
- Manufacturer
- United Orthopedic Corporation
- Category
- Medical Device — Knee Implant
- Hazard
- implant-misalignment
- device-orientation-defect
Distribution
Distributed in 9 states:
- CA
- CO
- FL
- IN
- KY
- MI
- NV
- TN
- TX
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