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Terminated

Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide, Rx Only,

FDA Recall Z-1912-2008 · Posted 2008-09-16

Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeLGW
Date Initiated2008-03-01
Date Terminated2012-06-05
Product Quantity3

Reason for Recall

Medtronic Model 3777-75 Octad 1x8 Leads, Lot V030733 contain accessory stylets that are not the correct length.

Firm Action

Consignees were sent a Medtronic Letter dated March 2008. The letter described the product model / serial number and problem. It gave the option in assisting in returning the product for replacement or credit. A Medtronic Inter-Office Memo was also issued to "Affected Field Personnel" . The memo described the product /problem and the action required . Contact Medtronic Neuromodulation Quality at 651-367-0628 if you have questions.

Root Cause

Mixed-up of materials/components

Distribution Pattern

NC, FL

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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