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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 FirmMay 20, 2026
Date PostedAugust 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2885-2026
Recall Event ID 99026
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductBrand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Code Information Product Number; UDI-DI Code; Lot Code: Product number 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51
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 an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
FDA Determined
Cause 2		Process design
ActionOn 03/11/2026, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that due the fact that the PSA Box Trial cannot be properly assembled with the Hinge Trial in the affected devices because of incomplete processing of the screw components, which may result in interference during assembly with the corresponding device. On 05/20/2026, the firm emailed an updated "URGENT: MEDCIAL DEVICE RECALL" Letter Customers are instructed: 1. Examine your inventory immediately to locate the affected product whose quantities and lot numbers are listed above. Please note the product may have already been returned. 2. Cease all use of these devices immediately and quarantine all affected devices in your territory for immediate return. 3. Customer Service will be contacting you regarding replacements. If you still have the product, you 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 your firm 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 Question - contact UOC Sr. Director of Sales Operations at 949.328.3366.
Quantity in Commerce2
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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