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U.S. Department of Health and Human Services

Class 2 Device Recall OrthoPediatrics PediLoc Locking Plate System

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 Class 2 Recall
OrthoPediatrics PediLoc Locking Plate System
see related information
Date Posted August 09, 2013
Recall Status1 Terminated on August 26, 2013
Recall Number Z-1941-2013
Recall Event ID 65828
Premarket Notification
510(K) Number
K083286 
Product Classification Screw, Fixation, Bone - Product Code HWC
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.
Code Information LOT 91300335 - Catalogue Number 01-1050-0002
Recalling Firm/
Manufacturer
OrthoPediatrics Corp
2850 Frontier Dr
Warsaw, Indiana 46582-7001
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Greg Teghtmeyer
574-268-6379
Manufacturer 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
FDA Determined
Cause 2
DESIGN: Process Design
Action On 7/24/13, OrthoPediatrics notified their consignees of this URGENT MEDICAL DEVICE RECALL via phone call. A follow-up email message was then sent with the recall notification, and then a hard copy of the notice was sent via certified letter. The notification addresses the affected product, recall issue, reply form instructions, and directs consignees to return affected product to OrthoPediatrics via a Fed-Ex return prepaid pouch. The firm directs consignees to forward the notification and reply form if the product was further distributed.
Quantity in Commerce 68
Distribution Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = ORTHOPEDIATRICS, CORP.
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