4.5mm PLEO Osteotomy Guide recallZ-0432-2013 · OrthoPediatrics Corp · initiated Oct 18, 2012
Class II Terminated All recalls posted in November 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from OrthoPediatrics Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0432-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 18, 2012
- Posted by the FDA
- Nov 22, 2012
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 24
- Product code
- HRS
- FDA submissions
- K083286
- Distribution
- Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX.
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.
Code information (models, lots, serial numbers)
Part number: 01-1050-0066 and 01-1050-0067 Lot numbers: 7861001 and 7861101 only
Other devices under the same FDA submission
1 device cleared under K083286 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PediLoc Locking Plate System 00-1050-3210Orthopediatrics Corp. · PLATE, FIXATION, BONE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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