FDA recall Z-2885-2026

Product

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

US Nationwide distribution in the states of Texas and Michigan.

Key facts

Status

Ongoing

Initiation date

2026-05-20

Report date

2026-08-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kaohsiung, Taiwan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2885-2026