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U2 Total Knee System PSA Box Trial
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MEDICAL DEVICE RECALLMODERATE

U2 Total Knee System PSA Box Trial

United Orthopedic recalls U2 Total Knee PSA Box Trials (models 9323-5511 thru 9323-5526) due to screw defect.

What to do

If you have a U2 Total Knee System PSA Box Trial, stop using it and contact United Orthopedic Corp. for instructions on returning the affected device.

Recalled
Listed
Updated
Recall No.
Z-2883-2026
Agency
FDA
Firm
United Orthopedic Corp.
Recall ID
99026
Status
ONGOING

Why it was recalled

United Orthopedic Corp. is recalling the PSA Box Trial components of the U2 Total Knee System, models 9323-5511 through 9323-5516 (left) and 9323-5521 through 9323-5526 (right), due to an incomplete process of the component screw by a subcontractor, which prevents proper assembly of the stem trial.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeRecall #UDI-DIModel/Catalog number
U2 Total Knee System Femoral valgus adaptor, left and right9323-5333, 25FB50, 9323-5334, 25FB51Z-2885-202604719886908084, 047198869080919323-5333 and 9323-5334
U2 Total Knee System PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-69323-5511, 25FB54, 9323-5512, 25FB55, 9323-5513, 25FB56, 9323-5514, 25FB57, 9323-5515, 25FB58, 9323-5516, 25FB59, 9323-5521, 25FB29, 9323-5522, 25FB30, 9323-5523, 25FB31, 9323-5524, 25FB32, 9323-5525, 25FB33, 9323-5526, 25FB34Z-2883-202604719886906929, 04719886906936, 04719886906943, 04719886906950, 04719886906967, 04719886906424, 04719886906974, 04719886906981, 04719886906998, 04719886907001, 04719886907018, 047198869070259323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526
USTAR II Knee System Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-69325-5711, 25FB41, 9325-5712, 25FB42, 9325-5713, 25FB43, 9325-5714, 25FB44, 9325-5715, 25FB45, 9325-5716, 25FB46, 9325-5721, 25FB35, 9325-5722, 25FB36, 9325-5723, 25FB37, 9325-5724, 25FB38, 9325-5725, 25FB39, 9325-5726, 25FB40Z-2884-202604719886907032, 04719886907049, 04719886907056, 04719886907063, 04719886907070, 04719886907087, 04719886907094, 04719886907100, 04719886907117, 04719886907124, 04719886907131, 047198869071489325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726
U2 Total Knee System Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm…9323-5335, 25FB64, 9323-5337, 25FB48, 9323-5339, 25FB52, 9323-5336, 25FB65, 9323-5338, 25FB49, 9323-5340, 25FB53Z-2886-202604719886906554, 04719886906578, 04719886906592, 04719886906561, 04719886906585, 047198869066089323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

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All recalls from United Orthopedic Corp.

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification