Z-0125-2020Class II

OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm...

Name: Z-0125-2020 OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm...
Creator: OrthoPediatrics Corp
Published: 2019-08-19
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2019-08-19 / Terminated / root cause: design

FDA source

OrthoPediatrics Corp began a recall of OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used... on 2019-08-19. FDA classified it as Class II and gives the reason as "Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0125-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-19
Posted: 2019-10-13
Terminated: 2020-10-26
Recalling firm: Orthopediatrics Corp
Product: 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
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 211 units
Distribution: Nationwide Foreign: Australia
Product codes and lots: Lot/serial number: 192432-B 192279-B 189808-A 187375-A 177577-A 183280-A 175221-A 174784-A UDI: 00841132149836

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0125-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0125-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-23	2019-10-12

Product code HSB

K172583Class IIOrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. / cleared 2018-05-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)