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
FDA Recall Z-2897-2026 · Posted 2026-08-06
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Recalling FirmUnited Orthopedic Corp.
Recall StatusOpen, Classified
Product CodeLWH
Date Initiated2026-03-19
Product Quantity3
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.
Firm Action
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
Distribution Pattern
US Nationwide distribution in the states of Texas and Michigan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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