Recall Z-0218-2020— OrthoPediatrics Corp

Name: FDA recall Z-0218-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-19

Class II · Terminated

Class II FDA medical device recall by OrthoPediatrics Corp, initiated 2019-08-19, terminated 2020-04-30. It names one FDA 510(k) clearance: K172583. Product: Model No. 01-1501-0032 (Child 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.. Reason: Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures..

Recalling firm: OrthoPediatrics Corp
Classification: Class II
Status: Terminated
Initiated: 2019-08-19
Terminated: 2020-04-30
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K172583 — OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc.·cleared 2018-05-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Model No. 01-1501-0032 (Child 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.

Reason for recall

Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

Data sourced from openFDA. This site is unofficial and independent of the FDA.