Z-2897-2026Class II

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

Name: Z-2897-2026 Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number...
Creator: United Orthopedic Corp.
Published: 2026-03-19
License: https://open.fda.gov/license/

United Orthopedic Corp. / initiated 2026-03-19 / Open, Classified / root cause: design

FDA source

United Orthopedic Corp. began a recall of 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... on 2026-03-19. FDA classified it as Class II and gives the reason as "Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2897-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-19
Posted: 2026-08-06
Recalling firm: United Orthopedic Corp.
Product: 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
Product code: LWH Counter, Sponge, Surgical
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 3
Distribution: US Nationwide distribution in the states of Texas and Michigan.
Product codes and lots: Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2897-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2897-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06
Z-2898-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06

Product code LWH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)