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FDA Enforcement Report Reflects Expansion of United Orthopedic Knee Trial Recall

An ongoing Class II recall of United Orthopedic U2 Total Knee System femoral trial components covers an expanded list of product codes and lot numbers.

4 reports on this incident · first at Aug 18, 2026, 3:11 a.m. ET

By AI ReporterWritten Aug 19, 2026, 7:30 p.m. ET
On August 12, 2026, an FDA enforcement report documented an expanded recall notice for involving its U2 Total Knee System PSA Box Trial components (recall number ). The action covers reusable knee femur prosthesis trials, specifically PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 under model catalog numbers 9323-5511 through 9323-5516 and 9323-5521 through 9323-5526. The full current list of affected identifying codes listed in the FDA record includes: Product Number 9323-5511 (UDI-DI 04719886906929, Lot 25FB54); Product Number 9323-5512 (UDI-DI 04719886906936, Lot 25FB55); Product Number 9323-5513 (UDI-DI 04719886906943, Lot 25FB56); Product Number 9323-5514 (UDI-DI 04719886906950, Lot 25FB57); Product Number 9323-5515 (UDI-DI 04719886906967, Lot 25FB58); Product Number 9323-5516 (UDI-DI 04719886906424, Lot 25FB59); Product Number 9323-5521 (UDI-DI 04719886906974, Lot 25FB29); Product Number 9323-5522 (UDI-DI 04719886906981, Lot 25FB30); Product Number 9323-5523 (UDI-DI 04719886906998, Lot 25FB31); Product Number 9323-5524 (UDI-DI 04719886907001, Lot 25FB32); Product Number 9323-5525 (UDI-DI 04719886907018, Lot 25FB33); and Product Number 9323-5526 (UDI-DI 04719886907025, Lot 25FB34). According to the FDA enforcement report, the recall was initiated on May 20, 2026, and remains for a total quantity of 2 units distributed in Texas and Michigan. The FDA record states the recall was initiated due to an incomplete process of the component screw by a subcontractor, which prevents proper assembly of the stem trial. The FDA classified the recall as . According to official FDA definitions, describes a situation where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Device registry records list the items as reusable surgical equipment used by operating-room staff during knee replacement procedures to test fit before implant placement. FDA database records show no other enforcement actions for

Earlier reports

  1. Aug 19, 2026, 6:59 p.m. ET

    FDA Classifies United Orthopedic Knee Prosthesis Trial Recall as Class II

    On August 12, 2026, the U.S. Food and Drug Administration assigned a Class II classification to the ongoing recall of United Orthopedic Corp. knee femur prosthesis trials under recall number Z-2883-2026. According to the FDA, a Class II designation indicates a situation where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

    The recall covers two units of the U2 Total Knee System PSA Box Trial (L, #1-6 and R, #1-6) with catalog numbers 9323-5511 through 9323-5516 and 9323-5521 through 9323-5526. The FDA enforcement report states that United Orthopedic Corp. voluntarily initiated the recall on May 20, 2026, due to an incomplete process of the component screw by a subcontractor, which prevents proper assembly of the stem trial. The affected units were distributed in Texas and Michigan, with lot numbers including 25FB54 through 25FB59 and 25FB29 through 25FB34.

    According to device registry records and published medical literature, these trial components are non-implantable, reusable surgical instruments used by surgical teams to assess joint sizing and fit during total knee replacement operations before fitting a final implant. FDA database records show no other enforcement actions listed for United Orthopedic Corp.

  2. Aug 19, 2026, 6:32 p.m. ET

    FDA Lists United Orthopedic Knee Trial Recall as Ongoing

    The U.S. Food and Drug Administration's enforcement record for United Orthopedic Corp.'s U2 Total Knee System trial components lists the recall status as Ongoing, as of a report date of August 12, 2026. The action is filed under recall number Z-2883-2026 and is classified Class II. The listed quantity is 2.

    The firm initiated the recall on May 20, 2026. The record gives the reason, in full: "Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail." That wording, including the spelling of "stem trail," is reproduced as it appears in the FDA record.

    Distribution is described in the record as "US Nationwide distribution in the states of Texas and Michigan."

    Under FDA's published recall definitions, a Class II recall covers a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or in which the probability of serious adverse health consequences is remote.

    The product as the record describes it

    • 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

    The record carries no further description of how the parts are used in surgery.

    Identifying codes

    The identifying codes are listed in the record as follows:

    • 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

    What the record does not say

    Because the status is ongoing, the record does not state how many of the affected units have been recovered or corrected, nor when the agency expects to terminate the recall. It also does not report any injuries. Nothing in the record addresses other enforcement actions involving the firm.

  3. Aug 18, 2026, 3:11 a.m. ETFirst report

    FDA Reports Ongoing Recall of United Orthopedic Knee Femur Prosthesis Trials

    An FDA enforcement report published on August 12, 2026, details an ongoing Class II recall initiated by United Orthopedic Corp. on May 20, 2026. The developing action involves a quantity of 2 reusable knee femur prosthesis trial components under recall number Z-2883-2026, distributed in Texas and Michigan.

    According to the FDA enforcement report, the recall was initiated due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. The recall covers the U2 Total Knee System, specifically PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6, with model/catalog numbers 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526. Identifying lot numbers in the report include 25FB54, 25FB55, 25FB56, 25FB57, 25FB58, 25FB59, 25FB29, 25FB30, 25FB31, 25FB32, 25FB33, and 25FB34.

    According to FDA guidance, Class II is a category used where product exposure may cause temporary or medically reversible harm, and where the chance of serious harm is remote. According to device registry listings, a reusable knee femur prosthesis trial is a surgical instrument used during knee replacement operations to check fit and size before the final implant is placed, handled by surgical teams rather than retail consumers. FDA listings document no other enforcement actions for United Orthopedic Corp.

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Revision history

  1. Version 119 Aug 2026, 23:30current

    First published.

  2. Version 118 Aug 2026, 07:11current

    First published.

  3. Version 119 Aug 2026, 22:59current

    First published.

  4. Version 119 Aug 2026, 22:32current

    First published.

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