Z-1941-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2013
- Initiation Date
- July 24, 2013
- Termination Date
- August 26, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68
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.
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
Distribution Pattern
Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
Code Information
LOT 91300335 - Catalogue Number 01-1050-0002