Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

3.2mm Drill Bit. This is a component within the PediLoc Recalled by OrthoPediatrics Corp Due to OrthoPediatrics has initiated a voluntary recall of Part...

Date: July 24, 2013
Company: OrthoPediatrics Corp
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact OrthoPediatrics Corp directly.

Affected Products

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.

Quantity: 68

Why Was This Recalled?

OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About OrthoPediatrics Corp

OrthoPediatrics Corp has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report