United Orthopedic Corp. recall records

6 reported ongoing

6 records in this archive. Latest source date May 20, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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 Soft...

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

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of Texas and Michigan.

Official source for Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 ...
FDA device enforcement

Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 ...

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

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of Texas and Michigan.

Official source for Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #...
FDA device enforcement

Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Ma...

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

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of Texas and Michigan.

Official source for Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catal...
FDA device enforcement

Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9...

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

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of Texas and Michigan.

Official source for Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left...
FDA device enforcement

Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic S...

Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of Texas and Michigan.

Official source for Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog ...
FDA device enforcement

Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic S...

Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of Texas and Michigan.

Official source for Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog ...

Reasons in these listed records

  • Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
  • Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

These examples come from this result page and are not a ranking of every recall reason.

Checking United Orthopedic Corp.

Is there a recall on united orthopedic corp. right now?

This archive contains 6 records, including 6 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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