Z-0432-2013 Class II Terminated
FDA device recall Z-0432-2013 was initiated by OrthoPediatrics Corp on Oct 18, 2012 and is designated Class II. 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… The recall status is terminated (terminated Sep 18, 2013). Affected quantity: 24.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 28, 2012
- Initiation Date
- Oct 18, 2012
- Termination Date
- Sep 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
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.
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.
Distribution Pattern
Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX.
Code Information
Part number: 01-1050-0066 and 01-1050-0067 Lot numbers: 7861001 and 7861101 only
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0432-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026