Home / Recalls / United Orthopedic Corp. / Z-2897-2026

Z-2897-2026 Class II Ongoing

Recalled by United Orthopedic Corp. — Kaohsiung

FDA device recall Z-2897-2026 was initiated by United Orthopedic Corp. on March 19, 2026 and is designated Class II. Reason for recall: Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. The recall status is ongoing. Affected quantity: 3.

Recall Details

Product Type
Devices
Report Date
August 12, 2026
Initiation Date
March 19, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3

Product Description

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 Surgical Instrument Component: No, N/A

Reason for Recall

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

Distribution Pattern

US Nationwide distribution in the states of Texas and Michigan.

Code Information

Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58

Other recalls by United Orthopedic Corp.

  • Z-2885-2026 Class II — Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and (May 20, 2026)
  • Z-2883-2026 Class II — Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA B (May 20, 2026)
  • Z-2884-2026 Class II — Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hin (May 20, 2026)
  • Z-2886-2026 Class II — Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2 (May 20, 2026)
  • Z-2898-2026 Class II — Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and (March 19, 2026)

FDA data resources