OrthoPediatrics PediNail Intramedullary Nailing System recallZ-0879-2017 · OrthoPediatrics Corp · initiated Nov 18, 2016
Class III Terminated All recalls posted in December 2016
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
Labeled as a 48mm Cortical Screw but measuring at 50mm
FDA root cause category: Labeling mix-ups
What the company is doing
OrthoPediatrics sent an URGENT MEDICAL DEVICE RECALL notification on November 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. . It is important that you carefully follow these recall instructions: " Please immediately take possession of any of these screws your customer may have or that you have, and quarantine them. Contact [email protected] to receive a Return Authorization Number. It is very important that we contain these devices rapidly and maintain them in quarantine. Replacement devices can be ordered from Customer Service. " The FedEx package you receive will contain a pre-addressed FedEx return label for the return of the recalled screw(s). " Included in this FedEx package is a Mandatory Reply Form for you to indicate the total number of affected screw(s) in your sets. We will be providing any additional follow up instructions as needed. If you have any questions call (574) 267-0865. For further questions regarding this recall , please call (574) 268-6379
Recall details
- Recall number
- Z-0879-2017
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Nov 18, 2016
- Posted by the FDA
- Dec 22, 2016
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 22 units
- Product code
- HSB
- FDA submissions
- K083726
- Distribution
- Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland.
Product description
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
Code information (models, lots, serial numbers)
Product Number: 10-1500-3048 Lot Number: 161421-G
Other devices under the same FDA submission
3 devices cleared under K083726 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- OrthoPediatrics PediNail Intramedullary Nailing System 10-1500-3044Orthopediatrics Corp. · PLATE, FIXATION, BONE1 report
- OrthoPediatrics PediNail Intramedullary Nailing System 10-1500-043Orthopediatrics Corp. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- OrthoPediatrics PediNail Intramedullary Nailing System 10-1500-094Orthopediatrics Corp. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 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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