Skip to main content
Recall Canary
U2 Total Knee System Femoral Offset Bushing
← Back to all recalls
MEDICAL DEVICE RECALLMODERATE

U2 Total Knee System Femoral Offset Bushing

U2 Total Knee System femoral offset bushing recalled due to incorrect engraved numbering that may cause misorientation.

What to do

If you have this product, stop using it and contact United Orthopedic Corp. for instructions on returning the affected bushing.

Recalled
Listed
Updated
Recall No.
Z-2897-2026
Agency
FDA
Firm
United Orthopedic Corp.
Recall ID
99025
Status
ONGOING

Why it was recalled

United Orthopedic Corp. is recalling the U2 Total Knee System Femoral offset bushing, 0mm and 4mm, model 9323-5310, due to a design issue causing incorrect engraved numbering on the implant, which could result in incorrect orientation of the implant.

Is mine affected?

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

U2 Total Knee System Femoral offset bushing

ProductLot codeRecall #UDI-DIModel/Catalog number
0mm and 4mm9323-5310, 25FC58Z-2897-2026047198869080609323-5310
2mm and 6mm9323-5312, 25FC64Z-2898-2026047198869080779323-5312

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

Other recent recalls from United Orthopedic Corp.

All recalls from United Orthopedic Corp.

← Back to all recalls

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