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U.S. Department of Health and Human Services

Class 2 Device Recall OrthoPediatrics Corp

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 Class 2 Device Recall OrthoPediatrics Corpsee related information
Date Initiated by FirmJuly 06, 2020
Create DateJuly 30, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2742-2020
Recall Event ID 86027
510(K)NumberK150600 
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
ProductOrthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease Model Number: 00-1300-6053
Code Information Lot Number: 108332-A  UDI: (01)0084113212400(10)108332A
Recalling Firm/
Manufacturer
OrthoPediatrics Corp
2850 Frontier Dr
Warsaw IN 46582-7001
For Additional Information ContactGreg Teghtmeyer
574-268-6379
Manufacturer Reason
for Recall
Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
FDA Determined
Cause 2
Under Investigation by firm
ActionOrthopedics issued Field Action Notice distributed via email on July 6, 2002 stating reason for recall , heath risk and action to take: Distributors are required, to perform sub-recall. The affected product must be returned to OrthoPediatrics Corporation. Replacement product will be provided. Please contact customer service to arrange return of the affected product. Distributors should retrieve affected product that may be with customers. No additional corrective actions need to be taken for product already implanted. Please complete and return the attached response form confirming your understanding of these instructions. 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 Commerce73 units
DistributionUS Nationwide distribution including in the states of Al, CA, FL, GA, KY, MI, MO, NC, NY, OH, TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NKB
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