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U.S. Department of Health and Human Services

Class 2 Device Recall Orthex

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  Class 2 Device Recall Orthex see related information
Date Initiated by Firm September 12, 2022
Date Posted November 22, 2022
Recall Status1 Open3, Classified
Recall Number Z-0277-2023
Recall Event ID 91098
510(K)Number K151881  
Product Classification Software for diagnosis/treatment - Product Code OSN
Product Orthex Large Bone Shoulder Bolt, model no. AS-17
Code Information UDI-DI: 00841132143155 Lots: 921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E
Recalling Firm/
Manufacturer		 OrthoPediatrics Corp
2850 Frontier Dr
Warsaw IN 46582-7001
For Additional Information Contact Mallory Trusty
574-268-6379
Manufacturer Reason
for Recall		 Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.
FDA Determined
Cause 2		 Under Investigation by firm
Action On September 12, 2022, the firm notified distributors of the recall. Distributors were asked to notify and retrieve affected devices from end users. Affected product must be returned to OrthoPediatrics. Replacement product will be provided. Customers should contact customer service to arrange return of the affected product. Customers who have patients in frames should be made aware of the possibility of Bolt breakage and continue monitoring their patients. Any questions regarding this recall can be directed to Joel Batts, Senior VP of Clinical and Regulatory Affairs, at OrthoPediatrics at jbatts@orthopediatrics.com or 574-367-5396.
Quantity in Commerce 1354 (594 US)
Distribution Domestic distribution to Foreign distribution to
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OSN and Original Applicant = VILEX IN TENNESSEE, INC
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