3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implant

FDA device recall Z-0276-2014 · posted 2013-11-14 · Terminated

Recall details

Recalling firm

OrthoPediatrics Corp

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

HRS

Quantity affected

7 units shipped

Distribution

Worldwide Distribution - US including Michigan and the countries of Ireland and Australia

Date initiated

2013-09-26

Date posted

2013-11-14

Date terminated

2013-12-26

Location

Warsaw, IN