PediNail Intramedullary Platform recallZ-0125-2020 · OrthoPediatrics Corp · initiated Aug 19, 2019
Terminated
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
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
FDA root cause category: Device Design
What the company is doing
OrthoPediatrics, Inc. notified Distributors by letter via email on 8/19/19 , stating reason for recall, health risk and action to take: Distributors have been instructed to review their inventory and the inventory at their clinical sites to recover the product. Questions contact: Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at [email protected] or 574-267-0897.
Recall details
- Recall number
- Z-0125-2020
- Status
- Terminated
- Initiated by the company
- Aug 19, 2019
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 211 units
- Product code
- HSB
- FDA submissions
- K172583
- Distribution
- Nationwide Foreign: Australia
Product description
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032
Code information (models, lots, serial numbers)
Lot/serial number: 192432-B 192279-B 189808-A 187375-A 177577-A 183280-A 175221-A 174784-A UDI: 00841132149836
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PediNail Intramedullary Platform 01-1503-0032Orthopediatrics Corp. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall0 reports
Product lines
Other devices under the same FDA submission
9 devices cleared under K172583 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- PediNail Intramedullary Platform 00-1504-0938Orthopediatrics Corp. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- PediNail Intramedullary Platform 00-1501-0722Orthopediatrics Corp. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1502-0732Orthopediatrics Corp. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1503-0934Orthopediatrics Corp. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1504-0934Orthopediatrics Corp. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1504-0936Orthopediatrics Corp. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1503-1032Orthopediatrics Corp. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1504-1030Orthopediatrics Corp. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1504-1138Orthopediatrics 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 16, 2026. Text above is shown as published by the FDA.
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