Class II U.S. Food and Drug Administration

United Orthopedic Corp. Brand Name: U2 Total Knee System Product Name: PSA Box Trial recall: Due to an incomplete process of the component screw by a subcontractor

Recall published 2 months ago

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2883-2026
Published
August 12, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
United Orthopedic Corp.
Product type
Medical devices
Units affected
2
Distribution
Nationwide
Made in
Taiwan
Lot / code info
Product Number; UDI-DI Code; Lot Code: Product Number 9323-5511; UDI-DI 04719886906929; Lot number 25FB54 Product Number 9323-5512; UDI-DI 04719886906936; Lot number 25FB55 Product Number 9323-5513; UDI-DI 04719886906943; Lot number 25FB56 Product Number 9323-5514; UDI-DI 04719886906950; Lot number 25FB57 Product Number 9323-5515; UDI-DI 04719886906967; Lot number 25FB58 Product Number 9323-5516; UDI-DI 04719886906424; Lot number 25FB59 Product Number 9323-5521; UDI-DI 04719886906974; Lot number 25FB29 Product Number 9323-5522; UDI-DI 04719886906981; Lot number 25FB30 Product Number 9323-5523; UDI-DI 04719886906998; Lot number 25FB31 Product Number 9323-5524; UDI-DI 04719886907001; Lot number 25FB32 Product Number 9323-5525; UDI-DI 04719886907018; Lot number 25FB33 Product Number 9323-5526; UDI-DI 04719886907025; Lot number 25FB34
UPC codes
04719886906929, 04719886906936, 04719886906943, 04719886906950, 04719886906967, 04719886906424, 04719886906974, 04719886906981, 04719886906998, 04719886907001, 04719886907018, 04719886907025

Products covered by this recall

Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A

Check your product

The notice names 26 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 04719886906929
  • 04719886906936
  • 04719886906943
  • 04719886906950
  • 04719886906967
  • 04719886906424
  • 04719886906974
  • 04719886906981
  • 04719886906998
  • 04719886907001
  • 04719886907018
  • 04719886907025

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25FB34 — 2

Model or item number

On the rating label, the box or the instruction sheet.

  • 9323-5511
  • 9323-5516
  • 9323-5521
  • 9323-55
  • 9323-5512
  • 9323-5513
  • 9323-5514
  • 9323-5515
  • 9323-5522
  • 9323-5523
  • 9323-5524
  • 9323-5525
  • 9323-5526

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

United Orthopedic Corp. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: United Orthopedic Corp. — No. 16 Luke 1st Rd., Kaohsiung

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was United Orthopedic Corp. medical devices recalled?

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04719886906929, 04719886906936, 04719886906943; lot code 25FB34 — 2; model number 9323-5511, 9323-5516, 9323-5521. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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