Device 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.
Z-1941-2013
Product summary
- Event
- Event 65828
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68
- Official record key
device-enforcement:Z-1941-2013
Official wording
Reason: 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
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.
Derived failure modes
-
Labeling or packaging
misbranding