The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1941-2013·Announced 2013-08-21

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Category
Medical Device — Surgical Instruments
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

Distributed nationwide across the United States.

The notice also names 15 states specifically:

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