Z-1378-2013Class II

Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320...

Name: Z-1378-2013 Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320...
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 Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330... 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-1378-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-20
Posted: 2013-05-24
Terminated: 2014-03-26
Recalling firm: Orthopedic Alliance, LLC
Product: Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral component, CR, cemented, #6, left 2103-1360 Femoral component, CR, cemented, #1, right 2103-1410 Femoral component, CR, cemented, #2, right 2103-1420 Femoral component, CR, cemented, #3, right 2103-1430 Femoral component, CR, cemented, #4, right 2103-1440 Femoral component, CR, cemented, #5, right 2103-1450 Femoral component, CR, cemented, #6, right 2103-1460 Femoral component, PS, #1, left 2103-3110 Femoral component, PS, #2, left 2103-3120 Femoral component, PS, #3, left 2103-3130 Femoral component, PS, #4, left 2103-3140 Femoral component, PS, #5, left 2103-3150 Femoral component, PS, #6, left 2103-3160 Femoral component,PS, #1, right 2103-3210 Femoral component,PS, #2, right 2103-3220 Femoral component,PS, #3, right 2103-3230 Femoral component,PS, #4, right 2103-3240 Femoral component,PS, #5, right 2103-3250 Femoral component,PS, #6, right 2103-3260 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: 136 units
Distribution: Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Product codes and lots: Catalog No. 2103-1310 2103-1320 2103-1330 2103-1340 2103-1350 2103-1360 2103-1410 2103-1420 2103-1430 2103-1440 2103-1450 2103-1460 2103-3110 2103-3120 2103-3130 2103-3140 2103-3150 2103-3160 2103-3210 2103-3220 2103-3230 2103-3240 2103-3250 2103-3260

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1378-2013
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

K120507Class IIUnited U2 Femoral Component, Ps, #7United Orthopedic Corporation / cleared 2012-05-04

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)