Z-1382-2013Class II

Femoral head, standard, 26mm, +0mm Femoral head,medium, 26mm,+3mm Femoral head, long, 26mm, +6mm Femoral...

Name: Z-1382-2013 Femoral head, standard, 26mm, +0mm Femoral head,medium, 26mm,+3mm Femoral head, long, 26mm, +6mm Femoral...
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 head, standard, 26mm, +0mm Femoral head,medium, 26mm,+3mm Femoral head, long, 26mm, +6mm Femoral head, X-long, 26mm, +9mm Femoral head, 28mm, -3mm... 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-1382-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-20
Posted: 2013-05-24
Terminated: 2014-03-26
Recalling firm: Orthopedic Alliance, LLC
Product: Femoral head, standard, 26mm, +0mm Femoral head,medium, 26mm,+3mm Femoral head, long, 26mm, +6mm Femoral head, X-long, 26mm, +9mm Femoral head, 28mm, -3mm Femoral head, 28mm, +0mm Femoral head, 28mm, +5mm Femoral head, 28mm, +10mm Femoral head, 32mm, -3mm Femoral head, 32mm, +0mm Femoral head, 32mm, +5mm Femoral head, 32mm, +10mm Femoral head, 36mm, -3mm Femoral head, 36mm, +0mm Femoral head, 36mm, +5mm Femoral head, 36mm, +10mm Variety of hip and knee implants and instruments, multiple uses.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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: 21 units
Distribution: Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Product codes and lots: Item No. 1201-1126 1201-1326 1201-1526 1201-1726 1201-1028 1201-1128 1201-1428 1201-1828 1201-1032 1201-1132 1201-1432 1201-1832 1201-1036 1201-1136 1201-1436 1201-1836

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1382-2013
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 LPH

K111546Class IIU2 Hip SystemUnited Orthopedic Corp. / cleared 2011-07-01

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)