U2 Total Knee System recallZ-2897-2026 · United Orthopedic Corp. · initiated Mar 19, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from United Orthopedic Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2897-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 19, 2026
- Posted by the FDA
- Aug 6, 2026
- Recalling firm
- United Orthopedic Corp.
- Quantity
- 3
- Product code
- LWH
- Distribution
- US Nationwide distribution in the states of Texas and Michigan.
Product description
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
Code information (models, lots, serial numbers)
Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- U2 Total Knee System 9323-5310United Orthopedic Corp. · Orthopedic Manual Surgical Instrument1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99025).
- Z-2898-2026 · Open, ClassifiedBrand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surg…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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