FDA Medical Device Recalls (openFDA)
OrthoPediatrics Corp: 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.
- Recall number
- Z-0207-2013
- 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.
- Status
- Terminated
- Initiated
- 2012-09-13
- Posted
- 2012-11-05
- Terminated
- 2013-09-18
- Reason
- 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
- 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
- 78
- Distribution
- Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
- Lot, serial or model codes
- Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710
- 510(k) numbers
- ["K024173"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3006460162
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28