OrthoPediatrics Recalls 4.5mm PLEO Osteotomy Guide Instruments
OrthoPediatrics Corp is recalling 24 units of the 4.5mm PLEO Osteotomy Guide because the device was not manufactured to design specifications and will not function as intended.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a manufacturing defect that prevents the instrument from functioning as intended, but no injuries or illnesses have been reported.
Plain-English summary
OrthoPediatrics Corp is recalling 24 units of the 4.5mm PLEO Osteotomy Guide Instrument. This instrument is an adjunct tool used with the OrthoPediatrics PediLock Extension Osteotomy Plate system, which is designed for pediatric extension osteotomy procedures on the distal femur. The recalled units are identified by part numbers 01-1050-0066 and 01-1050-0067 and lot numbers 7861001 and 7861101.
The recall was initiated after a sales representative reported that the drill guide tubes would not screw into the replenishment instrument. Investigation determined that the devices were not manufactured to design specifications and will not function as intended. The instrument is not required to perform the procedure and is not illustrated in the Surgical Technique manual.
The affected units were distributed nationwide, including in Ohio, North Carolina, Colorado, Florida, Indiana, Michigan, and Texas. Healthcare providers should stop using the affected instruments and contact OrthoPediatrics Corp for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- OrthoPediatrics Corp
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part number: 01-1050-0066 and 01-1050-0067 Lot numbers: 7861001 and 7861101 only
Distribution
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