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Recall Observatory FDA recall evidence

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

July 24, 2013

Class II

Product summary

Firm
OrthoPediatrics Corp
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

    reason.labeling_packaging · v1.0.0

    misbranding