Z-0207-2013Class II

Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally...

Name: Z-0207-2013 Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally...
Creator: OrthoPediatrics Corp
Published: 2012-09-13
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2012-09-13 / Terminated / root cause: manufacturing process

FDA source

OrthoPediatrics Corp began a recall of Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for... on 2012-09-13. FDA classified it as Class II and gives the reason as "A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not...". 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-0207-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-13
Posted: 2012-11-05
Terminated: 2013-09-18
Recalling firm: Orthopediatrics Corp
Product: Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated 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 (osteotomy) for correction of deformity.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
Root cause tag: manufacturing process
FDA root cause: Reprocessing Controls
Action: OrthoPediatrics Corp sent an Urgent Recall e-mail dated September 14, 2012, to all affected customers. The e-mail identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine all identified devices from the affected lot numbers immediately. Customers were also asked to complete the Mandatory Reply Form. Customers with questions should call 574-268-6379.
Quantity in commerce: 78
Distribution: Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
Product codes and lots: Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0207-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0207-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-05

Product code HSB

K024173Class IICds 3-Pd Hematology ControlsClinical Diagnostic Solutions, Inc. / cleared 2003-01-14

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)