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U.S. Department of Health and Human Services

Class 2 Device Recall U2 Total Knee System

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 Class 2 Device Recall U2 Total Knee Systemsee related information
Date Initiated by FirmMarch 19, 2026
Date PostedAugust 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2898-2026
Recall Event ID 99025
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductBrand 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 Surgical Instrument Component: No, N/A
Code Information Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64
FEI Number 1000395711
Recalling Firm/
Manufacturer		 United Orthopedic Corp.
No. 16 Luke 1st Rd.
Luzhu Dist.
Kaohsiung Taiwan
For Additional Information ContactMr. Calvin Lin
+886-22-9294567
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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 Commerce3
DistributionUS Nationwide distribution in the states of Texas and Michigan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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