Home / Recalls / United Orthopedic Corp. / Z-2885-2026

Z-2885-2026 Class II Ongoing

Recalled by United Orthopedic Corp. — Kaohsiung

FDA device recall Z-2885-2026 was initiated by United Orthopedic Corp. on May 20, 2026 and is designated Class II. Reason for recall: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. The recall status is ongoing. Affected quantity: 2.

Recall Details

Product Type
Devices
Report Date
August 12, 2026
Initiation Date
May 20, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

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: Manual Orthopedic Surgical Instrument Component: No

Reason for Recall

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

Distribution Pattern

US Nationwide distribution in the states of Texas and Michigan.

Code Information

Product Number; UDI-DI Code; Lot Code: Product number 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51

Other recalls by United Orthopedic Corp.

  • 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-2897-2026 Class II — Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and (March 19, 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