Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Softw

FDA device recall Z-2897-2026 · posted 2026-08-06 · Open, Classified

Recall details

Recalling firm

United Orthopedic Corp.

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.

Action taken

On 03/09/2026, the firm distributed an "URGENT: MEDICAL DEVICE RECALL" Letter informing customer that due the fact that the Femoral offset bushing in the affected devices is engraved with the incorrect numbering, and the rotational direction does not align with the intended orientation. Customers are instructed to: 1. Examine inventory immediately to locate the affected product whose quantities and lot numbers are listed in the letter. Note the product may have already been returned. 2. Cease all use of these devices immediately and quarantine all affected devices in their territory for immediate return. 3. Customer Service will be contacting customers regarding replacements. If customers still have the product, they are requested to immediately return the affected product using the prepaid airbills on RMA XXXX . a. Write the RMA number on the outside of the box clearly and legibly. b. Ship recalled product via Fed Ex standard overnight to: UOC USA INC. Attention: RMA# XXXX 16601 Hale Ave. Irvine, CA 92606 (Attached Shipping Label) 4. Additionally, if customers has further distributed the recall product, please provide that customer with a copy of this recall notification and assist them with the return of the product. 5. Complete and return the following page according to the instructions. For questions - contact UOC Sr. Director of Sales Operations at 949.328.3366.

Root cause

Device Design

Status

Open, Classified

Product code

LWH

Quantity affected

3

Distribution

US Nationwide distribution in the states of Texas and Michigan.

Date initiated

2026-03-19

Date posted

2026-08-06

Location

Kaohsiung, Luzhu Dist., Taiwan