Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9
FDA device recall Z-2883-2026 · posted 2026-08-05 · Open, Classified
Recall details
- Recalling firm
- United Orthopedic Corp.
- Reason for recall
- Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- Action taken
- On 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.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 2
- Distribution
- US Nationwide distribution in the states of Texas and Michigan.
- Date initiated
- 2026-05-20
- Date posted
- 2026-08-05
- Location
- Kaohsiung, Luzhu Dist., Taiwan
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNITED U2 TOTAL KNEE SYSTEM (K082424) | United Orthopedic Corp. | 2008-12-16 |