Lower riskMedical device recall · FDA · Published August 27, 2021
United Orthopedics USTAR II Knee System: Concentricity Failure Risk
United Orthopedics recalls USTAR II Knee System Segment Part (Catalog #2915-1025) due to concentricity and fatigue testing failures. Affected units may not meet safety standards.
“United Orthopedics USTAR II Knee System: Concentricity Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61883-united-orthopedics-ustar-ii-knee-system-concentricity-failure-risk. Based on FDA recall #Z-0110-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0110-2022%22&limit=1).
Uoc Usa Inc recalled United Orthopedics USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025 due to failing dynamic fatigue testing requirements, the FDA said on Aug. 27, 2021.
How to tell if you have it
Brand: United Orthopedics
Product: USTAR II Knee System Segment Part, RHS, 25 mm Length
Catalog #: 2915-1025
UDI Code: 04719872148197
Lot Code: 19E272H
Quantity: 3 devices
Distribution: U.S. Nationwide (CA, CO, NV)
The hazard
The product did not meet specifications for concentricity and failed to meet requirements of dynamic fatigue testing.
Context
GovInfoNow's records show United Orthopedics has faced other recent recalls, including the USTAR II Knee System Trial Hinge Box recall on May 20, 2026, and two U2 Total Knee System recalls on the same date. Other recent recalls of similar products include the U2 Total Knee System Femoral Valgus Adaptor Recall (May 20, 2026).
How to tell if you have this one
Check for the catalog number 2915-1025 on the product label. The UDI code is 04719872148197 and lot code 19E272H. This part was sold with the USTAR II Knee System.
Brand
United Orthopedics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the catalog number 2915-1025 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide: CA, CO, and NV No O.U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Nevada.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0110-2022 (August 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0110-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.