FDA Medical Device Recalls (openFDA)
OrthoPediatrics Corp: OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
- Recall number
- Z-0879-2017
- Recalling firm
- OrthoPediatrics Corp
- Product
- OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
- Status
- Terminated
- Initiated
- 2016-11-18
- Posted
- 2016-12-22
- Terminated
- 2017-07-27
- Reason
- Labeled as a 48mm Cortical Screw but measuring at 50mm
- Root cause
- Labeling mix-ups
- Action
- 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 logistics@orthopediatrics.com 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
- Quantity
- 22 units
- Distribution
- Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland.
- Lot, serial or model codes
- Product Number: 10-1500-3048 Lot Number: 161421-G
- 510(k) numbers
- ["K083726"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3006460162
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28