3.2mm Drill Bit. This is a component within the PediLoc recall
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.
Why was 3.2mm Drill Bit. This is a component within the PediLoc recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
LOT 91300335 - Catalogue Number 01-1050-0002
- 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.
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 68
- Distribution
- Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
- Recall date
- August 21, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)