Z-0110-2022Class II

United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog #...

Name: Z-0110-2022 United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog #...
Creator: Uoc Usa Inc
Published: 2021-08-27
License: https://open.fda.gov/license/

UOC USA Inc. / initiated 2021-08-27 / Terminated / root cause: design

FDA source

Uoc Usa Inc began a recall of United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025 on 2021-08-27. FDA classified it as Class II and gives the reason as "Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0110-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-27
Posted: 2021-10-14
Terminated: 2023-01-20
Recalling firm: UOC USA Inc.
Product: United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
Root cause tag: design
FDA root cause: Device Design
Action: On 08/27/2021, the Recalling Firm communicated via email a letter to customers/US surgeons informing them that they are initiating a product recall limited to its 25 mm segment from its knee system due to an out of specification condition that has the potential to pose a risk to patients. Customers are instructed to return unused products. For questions, contact the Director of Customer Service at 949-328-3366 or the Vice President of Marketing at 949-501-8575. On 09/16/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" notification letter to additional customers, who have not used or received any of the affected product, just to make them aware of the recall. The Urgent Medical Device Recall notification identified the reason for the recall, the potential risks associate with the use of the affected product, and instructed these customers that to notify the recalling firm is they have any of the affected products. The Recalling Firm can be contacted via email [email protected] or via phone at 949-501-8575. On 09/24/2021, the Recalling Firm communicated an updated "URGENT: MEDICAL DEVICE RECALL" Notification Letter informing customers that had received the affected recalled devices, of the recall action and the potential hazards associated with the affected products. In addition, this updated notification was also informing their customers, if they have any patients with the affected product implanted, the Recalling Firm's investigation did not reveal any reason to suggest that there is any imminent danger to the patient since the noted failure was primarily due to a fall from height. It is up to the medical discretion of the treating physicians regarding whether or not to notify the patient. It is also up to the medical discretion of the treating physician whether or not to consider a revision surgery to replace the affected segment. Any questions, contact: -Director of Customer Service at 949-328-3366, or -Vice President of
Quantity in commerce: 3 devices
Distribution: U.S. Nationwide: CA, CO, and NV No O.U.S.
Product codes and lots: Catalog Number: 2915-1025 UDI Code: 04719872148197 Lot Code: 19E272H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0110-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0110-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13

Product code KRO

K190100Class IIUSTAR II SystemUnited Orthopedic Corporation / cleared 2019-09-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)