Z-0348-2010

Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part #...

Name: Z-0348-2010 Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part #...
Creator: Orthopediatrics Corp
Published: 2009-07-21
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2009-07-21 / Terminated / root cause: design

FDA source

Orthopediatrics Corp began a recall of Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-034. The system is used for pediatric and small... on 2009-07-21. The reason FDA records is "The potential exists for the nails to fracture during insertion of the nail". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0348-2010
Status: Terminated
Initiated: 2009-07-21
Posted: 2010-05-12
Terminated: 2010-10-25
Recalling firm: Orthopediatrics Corp
Product: Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-034. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The potential exists for the nails to fracture during insertion of the nail.
Root cause tag: design
FDA root cause: Device Design
Action: Distributor consignees were notified by email dated July 28, 2009 and requested to return the recalled products and instrument sets. If there are questions regarding this issue, please contact Gary Barnett at 574-268-6379.
Quantity in commerce: 23 of all products
Distribution: Nationwide.
Product codes and lots: Lots 105477 and 105478.

Product code HSB

K083726Class IIPedinail Intramedullary Nailing SystemOrthoPediatrics Corp. / cleared 2009-03-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)