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U.S. Department of Health and Human Services

Class 2 Device Recall 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM

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 Class 2 Device Recall 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MMsee related information
Date Initiated by FirmSeptember 26, 2013
Date PostedNovember 14, 2013
Recall Status1 Terminated 3 on December 26, 2013
Recall NumberZ-0276-2014
Recall Event ID 66450
Product Classification Plate, fixation, bone - Product Code HRS
Product3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.
Code Information Part Number:. 00-0903-2634 and lot number 009U2
Recalling Firm/
Manufacturer		 OrthoPediatrics Corp
2850 Frontier Dr
Warsaw IN 46582-7001
For Additional Information Contact
574-268-6379
Manufacturer Reason
for Recall		The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.
FDA Determined
Cause 2		Labeling mix-ups
ActionOrthoPediatrics sent an Urgent Medical Device Recall letter dated September 26, 2013, to all affected customers.The letter identified the product the problem and the actions needed to be taken by the customer The sales representatives and distributors who have been identified via shipping records as having received one or more discrepant devices affected by this Recall were requested to quarantine the devices identified in this Recall by telephone on 18-September-2013. If you or any of your customers have any of these devices in the original packaging please take possession of them and quarantine them in preparation for returning them to OrthoPedlatrics. They are misbranded. If the Screw has already been removed from the original packaging and the original packaging has been discarded and the Screw placed in a sterilization tray, it need not be returned. For further questions please call ( 574) 268-6379.
Quantity in Commerce7 units shipped
DistributionWorldwide Distribution - US including Michigan and the countries of Ireland and Australia
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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