OrthoPediatrics recalls

OrthoPediatrics has 26 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 22 Feb 2023. 3 are still ongoing.

Total recalls26since 2012

Last 12 months0reported

Class I00% of total

Ongoing3latest 22 Feb 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 25 96%Class III 1 4%

Why orthopediatrics is recalled

Product types

By year

202314%
202214%
2020312%
2019312%
201814%
201714%
2016415%
201514%
2014312%
2013519%

Ongoing orthopediatrics recalls

3 active

Reported	Class	Recall	Company	Reason	Where
22 Feb 2023Device	CLASS II	Orthex Large Bone Shoulder Bolt recalled by OrthoPediatrics	OrthoPediatrics	Device Malfunction	IN
14 Sep 2022Device	CLASS II	Orthex External Fixation Wire Sharp Bayonet mm recalled	OrthoPediatrics	Other	Nationwide
5 Aug 2020Device	CLASS II	Orthopedics Rod, Cocr, Single Hex Length-The Response" recalled	OrthoPediatrics	Lead & Heavy Metals	Nationwide

All orthopediatrics recalls, newest first

26 total

Reported	Class	Recall	Company	Reason	Where
22 Feb 2023Device	CLASS II	Orthex Large Bone Shoulder Bolt recalled by OrthoPediatrics	OrthoPediatrics	Device Malfunction	IN
14 Sep 2022Device	CLASS II	Orthex External Fixation Wire Sharp Bayonet mm recalled	OrthoPediatrics	Other	Nationwide
5 Aug 2020Device	CLASS II	Orthopedics Rod, Cocr, Single Hex Length-The Response" recalled	OrthoPediatrics	Lead & Heavy Metals	Nationwide
15 Jul 2020Device	CLASS II	ACL Reconstruction System ShieldLoc implant component recalled	OrthoPediatrics	Packaging Defects	Nationwide
15 Jul 2020Device	CLASS II	ACL Reconstruction System ShieldLoc implant component recalled	OrthoPediatrics	Packaging Defects	Nationwide
6 Nov 2019Device	CLASS II	Model No. 01-1501-0032 (Child Nail Attachment Bolt). recalled	OrthoPediatrics	Lead & Heavy Metals	Nationwide
6 Nov 2019Device	CLASS II	Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component recalled	OrthoPediatrics	Lead & Heavy Metals	Nationwide
23 Oct 2019Device	CLASS II	Adolescent attachment bolt used recalled by OrthoPediatrics	OrthoPediatrics	Other	Nationwide
21 Feb 2018Device	CLASS II	Response 5/6.0 Spine System Pedicle Screw recalled by OrthoPediatrics	OrthoPediatrics	Other	Nationwide
14 Jun 2017Device	CLASS II	Response BandLoc 5/6.0 Tensioner Instrument The Tensioner recalled	OrthoPediatrics	Other	6 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.