Z-1129-2018Class II

U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system...

Name: Z-1129-2018 U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system...
Creator: United Orthopedic Corporation
Published: 2017-11-24
License: https://open.fda.gov/license/

United Orthopedic Corp. / initiated 2017-11-24 / Terminated / root cause: labeling and UDI

FDA source

United Orthopedic Corporation began a recall of U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or... on 2017-11-24. FDA classified it as Class II and gives the reason as "UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1129-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-24
Posted: 2018-03-19
Terminated: 2018-10-09
Recalling firm: United Orthopedic Corp.
Product: U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Urgent Field safety notice was distributed to customers on November 24, 2017 via e-mail. The letter identified the affected product, problem and actions to be taken. For further questions, please call (949) 328-3366.
Quantity in commerce: 14 pieces
Distribution: Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa.
Product codes and lots: Lot number 17B621AG

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1129-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1128-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19
Z-1129-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19

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)