Z-0219-2020Class II

Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform

Name: Z-0219-2020 Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform
Creator: OrthoPediatrics Corp
Published: 2019-08-19
License: https://open.fda.gov/license/

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

FDA source

OrthoPediatrics Corp began a recall of Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly... on 2019-08-19. FDA classified it as Class II and gives the reason as "Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0219-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-19
Posted: 2019-10-25
Terminated: 2020-04-30
Recalling firm: Orthopediatrics Corp
Product: Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On August 19, 2019, the firm notified customers of the issue via emailed notice titled Urgent Medical Device Recall. Customers were informed of the issue of binding between the attachment bolt and the intramedullary nail. The firm asked customers to return all attachment bolts in the field. The issue does not impact intramedullary nails that have been implanted. No additional corrective actions need to be taken for product already implanted. Any questions regarding this recall can be directed to Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at [email protected] or 574-267-0897.
Quantity in commerce: 969 total
Distribution: Worldwide distributions - US Nationwide distributions including states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KY, MD, MI, NC, NY, OH, OK, TN, TX, UT, VA, WA, and WI. Country of Australia.
Product codes and lots: 175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0219-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0218-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-25
Z-0219-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-25

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)