Device Recall djo surgical6.5 mm cancellous bone screw 의 리콜

Recall

62561

Class 2

Z-2146-2012

2012-07-16

2012-08-06

Terminated

United States

2012-12-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111018

One lot of the 010-55-030, 6.5 mm cancellous bone screw was recalled because a product complaint identified a mislabeling of the device. although the package label indicates size 30mm, the screw dimension is actually 25mm.

DJO Global sent an Urgent Field Safety Notice dated July 16, 2012, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the notice to all thoe who need to be aware within their organization or to any other organization where the potentially affected product was transferred, contact customers to place a replacement order and receive an RMA number, and return all affected devices using the RMA number. For questions customers should call 512-834-6255. For questions regarding this recall call 512-832-9500.