Z-0579-2014Class II

OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system...

Name: Z-0579-2014 OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system...
Creator: OrthoPediatrics Corp
Published: 2013-11-07
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2013-11-07 / Terminated / root cause: labeling and UDI

FDA source

OrthoPediatrics Corp began a recall of OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part... on 2013-11-07. FDA classified it as Class II and gives the reason as "Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0579-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-07
Posted: 2013-12-26
Terminated: 2014-05-09
Recalling firm: Orthopediatrics Corp
Product: OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: November 7, 2013 all consignees were notified of the Urgent Device recall via telephone calls and E-mail messages describing the product and reason for the recall,. The notice included directions to identify and quarantine the recalled devices returning product to OrthoPediatrics with completed return form to OrthoPediatrics via mail, email or courier service, or by photographing with a smart phone and emailing to [email protected] or by answering the recall specific questionsin an email to [email protected]
Quantity in commerce: 40
Distribution: Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
Product codes and lots: Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0579-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0579-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-26

Product code MBI

K130217Class IIOrthopediatrics Acl Reconstructive SystemOrthoPediatrics Corp. / cleared 2013-06-20

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)