Medtronic Accessory Kit , Titan Anchor Accessory Kit, 3550-39, Single Use, RX Only, Contents of the inner package are ST

FDA device recall Z-0500-2010 · posted 2009-12-11 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Medtronic is issuing a medical device correction for the Model 3550-39 Titan anchor due to the potential for lead migration as a result of insert separation within the anchor. The Medtronic Model 3550-39 Titan anchor accessory kit is designed for use with Medtronic percutaneous in-line connector spinal cord stimulation leads. Medtronic has received reports of separation of the titanium insert

Action taken

Consignees were sent a Medtronic "Urgent: Medical Device Correction" letter on 10/27/09. The letter was addressed to "Dear Healthcare Professional" and was dated October 2009. The letter described the problem and the product as well as the Scope and Potential Severity and gave Recommendations. Enclosures with the letter included: Use By Date (UBD) location on the Titan anchor accessory kit product packaging, Titan anchor patient letter, Reply card and Return envelope. Questions are direct to Medtronic via email at rs.neuroqa1a@medtronic.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LGW

Quantity affected

55,600

Distribution

All states in the United States including Puerto Rico. Australia, New Zealand, Canada, Andurra, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Netherlands, Ireland, Israel, Italy,

Date initiated

2009-10-27

Date posted

2009-12-11

Date terminated

2011-12-24

Location

Minneapolis, MN