The Recall Desk
HighFDA (Devices)·Z-0110-2022·Announced 2021-10-20

United Orthopedics USTAR II knee implant component recalled for specification failures

Uoc Usa Inc recalls 3 United Orthopedics USTAR II knee components that fail to meet manufacturing specifications for concentricity and dynamic fatigue testing. These defects could affect implant performance.

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: FDA Class II recall of a medical device with structural defects (concentricity specification failure and dynamic fatigue testing failure). No illnesses or injuries have been reported. This is a risk-of-harm product where injury has not yet been reported, placing it at Score 3 per the rubric.

Plain-English summary

United Orthopedics USTAR II Knee System Segment Part (Catalog #2915-1025, RHS, 25 mm length) has been recalled. The affected units do not meet manufacturing specifications for concentricity and failed dynamic fatigue testing requirements.

Three devices from lot code 19E272H were distributed in California, Colorado, and Nevada.

The concentricity specification defect and fatigue testing failure indicate potential structural integrity issues that could affect the implant's performance during use.

The recalled product

Product
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Manufacturer
Uoc Usa Inc
Category
Medical Device — Orthopedic Implant
Hazard
  • concentricity-defect
  • fatigue-failure

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 (1)

  • Catalog Number: 2915-1025 UDI Code: 04719872148197 Lot Code: 19E272H

Distribution

Distributed nationwide across the United States.

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