OrthoPediatrics Recalls 2.5mm Drill Bits Due to Packaging Labeling Error
OrthoPediatrics is voluntarily recalling 68 packaged 2.5mm drill bits because the packaging incorrectly lists the size as 3.2mm.
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 involves a minor labeling error (misbranding) on a medical device component, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
OrthoPediatrics Corp has initiated a voluntary recall of 68 units of the 2.5mm Drill Bit, Lot #91300335, which is a component of the PediLoc Locking Plate System. The recall is limited to drill bits that are still in their original packaging.
The reason for the recall is a misbranding error where the product description on the package incorrectly states the drill bit size as 3.2mm instead of the actual 2.5mm. The drill bit itself is not defective; the issue is solely with the labeling on the packaging.
The affected products were distributed nationwide, including in Missouri, Michigan, Washington, Florida, New York, Tennessee, Colorado, Arizona, Virginia, Texas, California, Minnesota, Louisiana, North Carolina, and Utah. Users should check their inventory for this specific lot number and catalog number (01-1050-0002) and stop using the affected packaged devices.
The recalled product
- Product
- 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
- Manufacturer
- OrthoPediatrics Corp
- Hazard
- Affected units
- 68
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)
- LOT 91300335 - Catalogue Number 01-1050-0002
Distribution
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