Reported Nov 28, 2012 · Terminated
4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This…
OrthoPediatrics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OrthoPediatrics Corp · 2850 Frontier Dr · Warsaw, IN · 46582-7001
Is this the product you have?
- 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument
- common nameGuide, Surgical, Instrument. The PediLoc¿ Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc¿ system. The PediLoc¿ Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates, left and right side specific. The PediLoc¿ Extension Osteotomy Plate is designed to fit the anatomy of the distal femur in children and adolescents, above the distal femoral physis. The distal section of the plate is designed so that three locking screws can be placed in the distal bone segment at an angle parallel to the distal femoral physis. The proximal portion of the plate is designed to accept locking or non-locking screws. The subject instrument of this recall is an adjunct instrument for the convenience of some surgeons who choose to use it. This instrument is not illustrated in the Surgical Technique, nor required to perform the procedure
- Lot codes and dates
- Part number01-1050-0066
- and 01-1050-0067 Lot numbers7861001 and 7861101 only
- Amount recalled
- 24
Where it was sold
Why it was recalled
Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
This product could cause temporary or reversible health problems — stop using it.
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