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
Distribution
Part of a larger recall action
This product is one of 3 recalled by United Orthopedic Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · United Orthopedic Corporation
See all →- HighUSTAR II Knee System implants recalled for potential stem misalignment
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Same hazard · implant misalignment
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