CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report
Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics recalled
OrthoPediatrics is recalling Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails), distributed nationwide in the US. The recall was initiated on 13 Sep 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0207-2013
- FDA event ID
- 63396
- Recalling firm
- OrthoPediatrics, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Sep 2012
- FDA classified
- 5 Nov 2012
- Reported
- 14 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 13 Sep 2012 | Recall initiated by company | |
| 5 Nov 2012 | Classified by FDA | +53 days |
| 14 Nov 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
Nationwide AlabamaColoradoFloridaGeorgiaIllinoisKentuckyMichiganNorth CarolinaNew YorkTexas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710
Where was it sold?
Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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