3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM 의 리콜

Recall

66450

Class 2

Z-0276-2014

2013-11-14

Terminated

United States

2013-12-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122418

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.

OrthoPediatrics 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.