Z-2796-2015Class II

3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm...

Name: Z-2796-2015 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm...
Creator: OrthoPediatrics Corp
Published: 2015-07-28
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2015-07-28 / Terminated / root cause: packaging

FDA source

OrthoPediatrics Corp began a recall of 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric... on 2015-07-28. FDA classified it as Class II and gives the reason as "The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2796-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-28
Posted: 2015-09-18
Terminated: 2016-03-17
Recalling firm: Orthopediatrics Corp
Product: 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2510, 3.5mm Non Locking Cortical Screw, Lot # 150192-J, initially by contacting customers via telephone, and then by e-mailing notification letters on 7/28/2015. Customers returned the 5 mislabled screws, which were repacked with correct labeling. All recall activities were complete as of 8/14/2015.
Quantity in commerce: 5
Distribution: Domestic: TN, IA Foreign: England VA/DOD: None
Product codes and lots: Part number 00-0903-2510, Lot number 150192-J

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2796-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2796-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-18

Product code HRS

K111086Class IIOrthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. / cleared 2011-06-17

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)