OrthoPediatrics Corp: Medical Device Recall in 2013 - (Recall #: Z-1941-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 24, 2013

Date Posted: August 21, 2013

Recall Number: Z-1941-2013

Event ID: 65828

Reason for Recall:

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

Status: Terminated

Product Quantity: 68

Code Information:

LOT 91300335 - Catalogue Number 01-1050-0002

Distribution Pattern:

Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.

Voluntary or Mandated:

Voluntary: Firm initiated