Recall Z-0500-2010 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Medtronic Accessory Kit , Titan Anchor Accessory Kit, 3550-39, Single Use, RX Only, Contents of the inner package are STERILE., Medtronic, Inc, Minneapolis, MN 55432-5604
| Date | Dec 11, 2009 (initiated Oct 27, 2009) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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, Kuwait, Lebanon, Luxembourg, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, Tukey, Un |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.