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"UNITED" USTAR II Knee System recallZ-0110-2022 · Uoc Usa Inc · initiated Aug 27, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Uoc Usa Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number
Z-0110-2022
Status
Terminated
Initiated by the company
Aug 27, 2021
Recalling firm
Uoc Usa Inc
Quantity
3 devices
Product code
KRO
FDA submissions
K190100
Distribution
U.S. Nationwide: CA, CO, and NV No O.U.S.

Product description

United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

42 devices cleared under K190100 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page