Device Recall Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft 의 리콜

Recall

35046

Class 2

Z-0849-06

2006-03-08

2006-05-06

Terminated

United States

2008-06-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45188

Medtronic neurosurgery has initiated this action because it was determined that two lots of the modular screwdriver blade components may exhiibt burrs along the tips of the screwdriver, which may prevent adequate engagement with the associated screws.

Medtronic Neurosurgery sent a Sales Representative Notification letter to the applicable Medtronic Sales Representative by mail and fax on March 8, 2006. A Sales Representative Notification Letter was provided to each Medtronic Sales Representative who had received the product or is responsible for an account who has received the product. This letter informed the applicable Sales Representative of the action and instructed them how to complete the Sales Representative Customer Product Accountability Letter. A Sales Representative Customer Product Accountability Letter was provided to each Medtronic Sales Representative who has received the product or is responsible for an account who has received the product. This letter requests the current product status, i.e., has the product been used, discarded or will it be returned to Medtronic Neurosurgery. Each letter will be individualized for each customer indicating the specific catalog number(s), lot number(s) and quantity that were shipped to that customer. It is the firm''s intention to have the Sales Representative exchange all affected product with replacement product during this process.