Z-2883-2026Class II

Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6...

Name: Z-2883-2026 Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6...
Creator: United Orthopedic Corp.
Published: 2026-05-20
License: https://open.fda.gov/license/

United Orthopedic Corp. / initiated 2026-05-20 / Open, Classified / root cause: manufacturing process

FDA source

United Orthopedic Corp. began a recall of Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521... on 2026-05-20. FDA classified it as Class II and gives the reason as "Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2883-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-20
Posted: 2026-08-05
Recalling firm: United Orthopedic Corp.
Product: Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 2
Distribution: US Nationwide distribution in the states of Texas and Michigan.
Product codes and lots: Product Number; UDI-DI Code; Lot Code: Product Number 9323-5511; UDI-DI 04719886906929; Lot number 25FB54 Product Number 9323-5512; UDI-DI 04719886906936; Lot number 25FB55 Product Number 9323-5513; UDI-DI 04719886906943; Lot number 25FB56 Product Number 9323-5514; UDI-DI 04719886906950; Lot number 25FB57 Product Number 9323-5515; UDI-DI 04719886906967; Lot number 25FB58 Product Number 9323-5516; UDI-DI 04719886906424; Lot number 25FB59 Product Number 9323-5521; UDI-DI 04719886906974; Lot number 25FB29 Product Number 9323-5522; UDI-DI 04719886906981; Lot number 25FB30 Product Number 9323-5523; UDI-DI 04719886906998; Lot number 25FB31 Product Number 9323-5524; UDI-DI 04719886907001; Lot number 25FB32 Product Number 9323-5525; UDI-DI 04719886907018; Lot number 25FB33 Product Number 9323-5526; UDI-DI 04719886907025; Lot number 25FB34

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2883-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2883-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05
Z-2884-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05
Z-2885-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05
Z-2886-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05

Product code JWH

K082424Class IIUnited U2 Total Knee SystemUnited Orthopedic Corp. / cleared 2008-12-16

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)