Z-0432-2013Class II

4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system...

Name: Z-0432-2013 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system...
Creator: OrthoPediatrics Corp
Published: 2012-10-18
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2012-10-18 / Terminated / root cause: manufacturing process

FDA source

OrthoPediatrics Corp began a recall of 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name... on 2012-10-18. FDA classified it as Class II and gives the reason as "Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0432-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-18
Posted: 2012-11-22
Terminated: 2013-09-18
Recalling firm: Orthopediatrics Corp
Product: 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc system. The PediLoc Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates, left and right side specific. The PediLoc Extension Osteotomy Plate is designed to fit the anatomy of the distal femur in children and adolescents, above the distal femoral physis. The distal section of the plate is designed so that three locking screws can be placed in the distal bone segment at an angle parallel to the distal femoral physis. The proximal portion of the plate is designed to accept locking or non-locking screws. The subject instrument of this recall is an adjunct instrument for the convenience of some surgeons who choose to use it. This instrument is not illustrated in the Surgical Technique, nor required to perform the procedure.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: OrthoPediatrics sent an "URGENT RECALL" e-mail of the Trochar Scalpel Instrument to all affected customers. The e-mail identifies the product, problem, and actions to be taken by the customers. The e-mail states that the instrument has been manufactured incorrectly and will not work (function as intended). The threads in the instrument are faulty and the guide tubes will not thread in correctly. Customers will receive follow up information.
Quantity in commerce: 24
Distribution: Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX.
Product codes and lots: Part number: 01-1050-0066 and 01-1050-0067 Lot numbers: 7861001 and 7861101 only

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0432-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0432-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-22

Product code HRS

K083286Class IIOrthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. / cleared 2009-01-30

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)