FDA Device recall Z-0432-2013
4.5mm PLEO Osteotomy Guide
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of 4.5mm PLEO Osteotomy Guide by Orthopediatrics, citing 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 w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0432-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-18 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Orthopediatrics |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Part number: 01-1050-0066 and 01-1050-0067 Lot numbers: 7861001 and 7861101 only |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0432-2013%22
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