Z-2560-2014Class II

ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm

Name: Z-2560-2014 ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm
Creator: OrthoPediatrics Corp
Published: 2014-07-25
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2014-07-25 / Terminated / root cause: manufacturing process

FDA source

OrthoPediatrics Corp began a recall of ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a... on 2014-07-25. FDA classified it as Class II and gives the reason as "Weld fractures on the Sleeve Installation Tool for ACL reconstruction system". 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-2560-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-25
Posted: 2014-08-29
Terminated: 2015-05-19
Recalling firm: Orthopediatrics Corp
Product: ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: OrthoPediatrics sent a Notification letter dated July 25, 2014 to all affected customers. The letter Identified the affected product, problem and actions to be taken. The letter informed customers to take immediate possession of all affected product within their control and at any of their health care facilities and immediately return the recalled device(s) to OrthoPediatrics Corp. This notice and the attached Reply Form should be forwarded if the affected product was further distributed. .
Quantity in commerce: 56 units
Distribution: US Nationwide Distribution.
Product codes and lots: Part #: Lot Code: 01-1008-0040 132762 01-1008-0041 F132764, F132763 01-1008-0042 F132763, F132764 01-1008-0043 F132765, F132766 01-1008-0044 F132766, F132765 01-1008-0045 F132768 01-1008-0046 F132769 01-1008-0047 F132770

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2560-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2560-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29

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)