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U.S. Department of Health and Human Services

Class 2 Device Recall Adolescent Nail Attachment Bolt

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  Class 2 Device Recall Adolescent Nail Attachment Bolt see related information
Date Initiated by Firm August 19, 2019
Create Date October 25, 2019
Recall Status1 Terminated 3 on April 30, 2020
Recall Number Z-0219-2020
Recall Event ID 83884
510(K)Number K172583  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.
Code Information 175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C 
Recalling Firm/
Manufacturer		 OrthoPediatrics Corp
2850 Frontier Dr
Warsaw IN 46582-7001
For Additional Information Contact Greg Teghtmeyer
574-267-0840
Manufacturer Reason
for Recall		 Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On August 19, 2019, the firm notified customers of the issue via emailed notice titled Urgent Medical Device Recall. Customers were informed of the issue of binding between the attachment bolt and the intramedullary nail. The firm asked customers to return all attachment bolts in the field. The issue does not impact intramedullary nails that have been implanted. No additional corrective actions need to be taken for product already implanted. Any questions regarding this recall can be directed to Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at kanderson@orthopediatrics.com or 574-267-0897.
Quantity in Commerce 969 total
Distribution Worldwide distributions - US Nationwide distributions including states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KY, MD, MI, NC, NY, OH, OK, TN, TX, UT, VA, WA, and WI. Country of Australia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = OrthoPediatrics, Inc.
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