FDAFDA · Food and drugs·Recall number Z-1941-2013
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.
Published August 21, 2013 · Recall initiated: July 24, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- OrthoPediatrics Corp
- Distributor
- Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
- Lot
- LOT 91300335 - Catalogue Number 01-1050-0002
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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