Z-1380-2013Class II

UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE...

Name: Z-1380-2013 UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE...
Creator: Orthopedic Alliance LLC
Published: 2013-02-20
License: https://open.fda.gov/license/

Orthopedic Alliance, LLC / initiated 2013-02-20 / Terminated / root cause: labeling and UDI

FDA source

Orthopedic Alliance LLC began a recall of UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small... on 2013-02-20. FDA classified it as Class II and gives the reason as "The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician...". 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-1380-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-20
Posted: 2013-05-24
Terminated: 2014-03-26
Recalling firm: Orthopedic Alliance, LLC
Product: UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE Onset Patella, 3 pegs, large 2403-1040 UKNEE Onset Patella, 3 pegs,X-large 2403-1050 Variety of hip and knee implants and instruments, multiple uses.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
Quantity in commerce: 57 units
Distribution: Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Product codes and lots: Catalog No. 2401-1010 2401-1020 2401-1030 2401-1040 2403-1010 2403-1020 2403-1030 2403-1040 2403-1050

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1380-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1378-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1379-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1380-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1381-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1382-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1383-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1384-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1385-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1386-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24

Product code JWH

K103733Class IIUnited U2 Xpe Total Knee SystemUnited Orthopedic Corporation / cleared 2011-08-02

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)